Clinical Trials Register

Summary
EudraCT Number:	2023-000029-10
Sponsor's Protocol Code Number:	DESC-HBR
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Trial now transitioned
Date on which this record was first entered in the EudraCT database:	2023-01-17
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2023-000029-10

A.3

Full title of the trial

De-Escalation of Antiplatelet Therapy to Evaluate Platelet Reactivity and Clinical Outcomes after Coronary Stenting in Patients at High Bleeding Risk and Recent Acute Coronary Syndrome: DESC-HBR trial

De-Escalation di Terapia Antiaggregante per la valutazione della Reattività Piastrinica ed Outcome Clinici dopo Stenting Coronarico in Pazienti ad elevato Rischio Emorragico con recente Sindrome Coronarica Acuta: Trial DESC-HBR

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Early reduction of antiplatelet therapy in patients with Acute Coronary Syndrome treated with stent implantation and at high risk of bleeding

Riduzione anticipata della terapia antiaggregante in pazienti con Sindrome Coronarica Acuta trattata con impianto di stent e ad elevato rischio di sanguinamento

A.3.2

Name or abbreviated title of the trial where available

DESC-HBR

A.4.1

Sponsor's protocol code number

DESC-HBR

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Azienda Ospedaliera Universitaria Gaetano Martino Messina
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Ministero della salute - Bando della ricerca finalizzata 2021 - grant GR-2021-12374500
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Mediolanum Cardio Resarch Srl
B.5.2	Functional name of contact point	Clinical Operations
B.5.3	Address:
B.5.3.1	Street Address	Via G. Carducci n. 19
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20123
B.5.3.4	Country	Italy
B.5.4	Telephone number	026123141
B.5.6	E-mail	jori@mcr-med.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	brilique
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Brilique
D.3.2	Product code	[Ticagrelor]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TICAGRELOR
D.3.9.1	CAS number	274693-27-5
D.3.9.2	Current sponsor code	ticagrelor
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	90
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	prasugrel
D.3.2	Product code	[prasugrel]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRASUGREL
D.3.9.1	CAS number	389574-19-0
D.3.9.2	Current sponsor code	prasugrel
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	prasugrel
D.3.2	Product code	[prasugrel]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	PRASUGREL
D.3.9.1	CAS number	389574-19-0
D.3.9.2	Current sponsor code	prasugrel
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.2	Country which granted the Marketing Authorisation	Italy
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Clopidogrel
D.3.2	Product code	[clopidogrel]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CLOPIDOGREL
D.3.9.1	CAS number	113665-84-2
D.3.9.2	Current sponsor code	clopidrogel
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Brilique
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
D.2.1.2	Country which granted the Marketing Authorisation	Sweden
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Brilique
D.3.2	Product code	[ticagrelor]
D.3.4	Pharmaceutical form	Film-coated tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TICAGRELOR
D.3.9.1	CAS number	274693-27-5
D.3.9.2	Current sponsor code	Ticagrelor
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	60
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

High bleeding risk (HBR) patients with a recent acute coronary syndrome (ACS ) who have undergone percutaneous coronary intervention (PCI) and are on double antiplatelet therapy (DAPT)

Pazienti ad alto rischio di sanguinamento (HBR) con sindrome coronarica acuta (SCA) recente trattata con rivascolarizzazione coronarico per via percutanea (PCI) e in trattamento con doppia antiaggregazione (DAPT)

E.1.1.1

Medical condition in easily understood language

acute cardiac ischemia

ischemia acuta del miocardio

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	PT
E.1.2	Classification code	10051592
E.1.2	Term	Acute coronary syndrome
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

The primary objective is to evaluate the pharmacodynamic effect of 3 different regimens of P2Y12 inhibitor de-escalation (prasugrel 5mg, ticagrelor 60mg/bid or clopidogrel 75mg) versus full-dose potent P2Y12 inhibitor (prasugrel 10mg or ticagrelor 90mg bid) on platelet reactivity, and to evaluate which treatment achieves the highest proportion of patients in the optimal platelet reactivity (OPR) at treatment steady-state.

Confrontare l'impatto della de-escalation dell'inibitore P2Y12 con clopidogrel 75mg, prasugrel 5mg o ticagrelor 60mg bid, rispetto agli inibitori potenti P2Y12 a dose piena (prasugrel 10mg o ticagrelor 90mg bid) in termini di percentuale di pazienti con reattività piastrinica ottimale (OPR).

E.2.2

Secondary objectives of the trial

The key secondary objective is to evaluate the clinical impact of P2Y12 inhibitor de-escalation versus full-dose potent P2Y12 inhibition on major, minor and nuisance bleeding according to the bleeding academic research consortium definition (BARC 1-5 bleeding) at 5 months after randomization. Other secondary objectives will be to evaluate ischemic and net clinical events and quality of life in the four treatment arms. Platelet reactivity at 1 and 2 weeks after P2Y12 inhibitor discontinuation will be evaluated at the end of the study, or anytime during the study, in patients permanently discontinuing treatment

L'obiettivo secondario principale è valutare l'impatto clinico della de-escalation dell'inibitore P2Y12 rispetto all'inibizione potente di P2Y12 a dose piena sul sanguinamento maggiore, minore o minimale secondo la definizione del consorzio di ricerca accademica (sanguinamento BARC 1-5) a 5 mesi dalla randomizzazione. Altri obiettivi secondari saranno la valutazione degli eventi ischemici e degli eventi clinici netti e della qualità della vita nei quattro bracci di trattamento. Nei pazienti che interrompono definitivamente il trattamento sarà valutata la reattività piastrinica a 1 e 2 settimane dopo l'interruzione dell'inibitore P2Y12 alla fine dello studio, o in qualsiasi momento durante lo studio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Informed Consent signed and dated.
- Patients deemed at HBR according to standard definitions (i.e. PRECISE-DAPT =25 or HBR-ARC with at least 1 major or 2 minor criteria) (Table 1).
- Treated with PCI due to a recent ACS (i.e. unstable angina, non-ST segment elevated myocardial infarction or ST segment elevated myocardial infarction) 30 ±7 days earlier.
- Treated with DAPT with full-dose potent P2Y12 inhibitors (e.g. prasugrel 10mg or ticagrelor 90mg bid) according to international guidelines recommendations

- Consenso informato firmato e datato
- Pazienti ritenuti ad alto rischio di sanguinamento secondo le definizioni standard (PRECISE-DAPT =25 o presenza di almeno 1 criterio clinico maggiore o 2 minori secondo l’Academic Research Consortium for High Bleeding Risk (ARC-HBR)).
- Pazienti trattati con rivascolarizzazione coronarica per via percutanea (PCI) per una recente SCA (angina instabile, infarto del miocardio senza sovraslivellamento del tratto ST, infarto del miocardio con sovraslivellamento del tratto ST) nei precedent 30±7 giorni
- In trattamento con doppia terapia antiaggregante piastrinica (DAPT) con inibitori P2Y12 potenti a dose piena (ad es. prasugrel 10 mg o ticagrelor 90 mg/bid) in base alle raccomandazioni delle line guida.

E.4

Principal exclusion criteria

• Known intolerance, hypersensitivity or contraindication (including active bleeding) to aspirin, clopidogrel, prasugrel or ticagrelor
• Indication to oral anticoagulation
• Indication to prolonged treatment with full-dose potent P2Y12 inhibitors (e.g. previous stent thrombosis, stenting of last remaining vessel, stent with indication for longer-term DAPT, perceived very high coronary ischemic risk etc.)
• Any planned major surgery or interventional procedure requiring treatment modification
• Prior transient ischemic attack, ischemic or haemorrhagic stroke
• Severe hepatic insufficiency (Child-Pugh class C)
• Ongoing therapy with strong CYP3A inducers or strong CYP3A inhibitors (e.g. ketoconazole, clarithromycin, nefazodone, ritonavir, atazanavir etc.)
• Women who are pregnant or breast feeding or with potential to become pregnant during the course of the study (age < 55 years and last menstruation within the last 12 months) without a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices

• intolleranza nota, ipersensibilità o controindicazione (incluso sanguinamento attivo) ad aspirina, clopidogrel, prasugrel o ticagrelor;
• indicazione all'anticoagulazione orale;
• indicazione al trattamento prolungato con inibitori P2Y12 potenti a dose piena (ad es. per precedente trombosi dello stent, rivascolarizzazione di vasi non target, stent con indicazione a DAPT a lungo termine, rischio ischemico coronarico valutato come molto elevato ecc.);
• qualsiasi intervento chirurgico maggiore programmato o procedura interventistica che richieda una modifica del trattamento;
• precedente attacco ischemico transitorio, ictus ischemico o emorragico;
• grave insufficienza epatica (classe C di Child-Pugh);
• terapia in corso con forti induttori del CYP3A o forti inibitori del CYP3A (ad es. ketoconazolo, claritromicina, nefazodone, ritonavir, atazanavir ecc.);
• donne in gravidanza o allattamento o che non utilizzano metodi contraccettivi adeguati per l'intera durata dello studio, come contraccettivi orali, iniettabili o impiantabili, o dispositivi contraccettivi intrauterine.

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint of the study is the incidence of optimal platelet reactivity (OPR) measured by means of the VerifyNow system (Accumetrics, San Diego, CA, USA), 2 hours after drug MD at 14±2 days from study inclusion. OPR will be defined as a PRU between 85 and 208 reactivity units according to international expert consensus.

L'outcome primario è la percentuale di pazienti nell'intervallo OPR misurata con il sistema VerifyNow, rilevata al picco di concentrazione del farmaco dopo 14±2 giorni di trattamento con la dose di mantenimento (MD). OPR è definito come un'unità di reattività piastrinica (PRU) compresa tra 85 e 208 unità di reattività, come da consenso internazionale.

E.5.1.1

Timepoint(s) of evaluation of this end point

14 +/- 2 days

14 +/- 2 giorni

E.5.2

Secondary end point(s)

Key secondary endpoint of the study is the incidence of nuisance, minor or major bleeding according to the BARC definition (BARC 1-5).; Platelet reactive units (PRU) at VerifyNow system and Platelet-derived thrombogenicity at Total Thrombus Formation (T-TAS) before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration and before MD at 14±2 days from study inclusion; The proportion of high platelet reactivity (HPR) defined as PRU > 208, and the proportion of low platelet reactivity (LPR), defined as PRU < 85, measured through the VerifyNow system before first randomized treatment administration (baseline), 2 hours after the first randomized treatment administration, before MD at 14±2 days from study inclusion and at 2 hours after drug MD administration at 14±2 days from study inclusion.; Adverse clinical events, assessed at each visit and up to 5 months after randomization. They include: death, cardiac death, non-fatal myocardial infarction, non-fatal stroke, urgent target vessel revascularization, definite/probable stent thrombosis and net adverse clinical events.

Un outcome secondario principale sarà il sanguinamento maggiore, minore o minimale secondo la definizione di sanguinamento del consorzio di ricerca accademica (BARC), rilevato fino a 5 mesi.; la reattività piastrinica con il sistema VerifyNow ed il sistema T-TAS prima della prima somministrazione del trattamento randomizzato (basale), 2 ore dopo la prima somministrazione del trattamento randomizzato e prima del MD a 14±2 giorni dall'inclusione dello studio; La percentuale di alta reattività piastrinica (HPR), definita come PRU > 208, e la percentuale di bassa reattività piastrinica (LPR), definita come PRU < 85, misurata attraverso il sistema VerifyNow prima della prima somministrazione del trattamento randomizzato (basale), 2 ore dopo la prima somministrazione del trattamento randomizzato, prima del MD a 14±2 giorni dall'inclusione dello studio e a 2 ore dopo la somministrazione del farmaco MD a 14±2 giorni dall'inclusione dello studio.; Eventi clinici avversi, valutati ad ogni visita e fino a 5 mesi dopo la randomizzazione. Includono: more, morte cardiaca, infarto miocardico non fatale, ictus non fatale, rivascolarizzazione urgente del vaso target, trombosi dellon stent certa/probabile,e gli eventi clinici avversi netti (NACE)

E.5.2.1

Timepoint(s) of evaluation of this end point

5 months; 14 +/- 2 days; 14 +/- 2 days; up to 5 months after the randomization

5 mesi; 14 +/- 2 giorni; 14 +/- 2 giorni; fino a 5 mesi dalla randomizzazione

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

Yes

E.6.12

Pharmacoeconomic

Yes

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

160

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

200

F.4.2.2

In the whole clinical trial

200

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

according to medical judgment

secondo giudizio medico

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2023-03-24

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2023-02-14

P. End of Trial
P.	End of Trial Status	Trial now transitioned

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