Clinical Trials Register

Summary
EudraCT Number:	2014-002171-29
Sponsor's Protocol Code Number:	GE-IDE-MucT001-14
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-01-26
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2014-002171-29

A.3

Full title of the trial

Intensified Loading with Prasugrel versus Moderate Loading with Clopidogrel in PCI-treated Patients with Biomarker-Negative Angina pectoris.

Prasugrel és clopidogrel telítő adagok összevetése biomarker-negatív angina pectoris miatt végzett koronária intervenció esetén: SASSICAIA vizsgálat

A.3.1

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

Peri-interventional intensified versus moderate platelet inhibition in patients with coronary artery disease without myocardial infarction

Erélyes vagy mérsékelt vérlemezke-gátló kezelés tervezett, nem szívinfarktus miatti szívkoszorúér tágítás alatt

A.3.2

Name or abbreviated title of the trial where available

SASSICAIA

A.4.1

Sponsor's protocol code number

GE-IDE-MucT001-14

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	Hospital of the University of Munich, Grosshadern
B.1.3.4	Country	Germany
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	Hospital University of Munich, Grosshadern
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	University Hospital of Munich, Grosshadern
B.5.2	Functional name of contact point	I. Med. Klinik und Poliklinik
B.5.3	Address:
B.5.3.1	Street Address	Marchioninistr. 15
B.5.3.2	Town/ city	Munich
B.5.3.3	Post code	81377
B.5.3.4	Country	Germany
B.5.4	Telephone number	+4989440073053
B.5.5	Fax number	+4989440076064
B.5.6	E-mail	julinda.mehilli@med.uni-muenchen.de

D. IMP Identification
D.IMP: 1
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	Efient
D.2.1.1.2	Name of the Marketing Authorisation holder	Daiichi Sankyo Europe GmbH
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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.3.4	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	150322-43-3
D.3.9.3	Other descriptive name	Efient
D.3.9.4	EV Substance Code	SUB30236
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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.2.1.1.1	Trade name	Plavix
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi Clir SNC
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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.3.4	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.3.9.3	Other descriptive name	CLOPIDOGREL
D.3.9.4	EV Substance Code	SUB13395MIG
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	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
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

Biomarker-negative patients with an indication for percutaneous coronary intervention

Biomarker negativ betegek, akiknél percutan koronária intervenció végrehajtása javasolt.

E.1.1.1

Medical condition in easily understood language

Patient with chest pain without laboratory and electrocardiographic signs of acute heart attack who need a treatment of coronary blockages

Szívkoszorúér tágításra kerülő, nem szívinfarktusos betegek

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	19.1
E.1.2	Level	PT
E.1.2	Classification code	10011078
E.1.2	Term	Coronary artery disease
E.1.2	System Organ Class	10007541 - Cardiac disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	19.1
E.1.2	Level	LLT
E.1.2	Classification code	10074572
E.1.2	Term	Multiple vessel coronary artery disease
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

To assess the efficacy of intensified loading with single oral administration of 60 mg prasugrel compared to loading with high-dose 600 mg clopidogrel in patients with biomarker negative angina undergoing PCI regarding the clinical outcomes at 30-day after index PCI

Az koronária intervenció előtt adott 60 mg-os prasugrel telítőadag, majd 75 mg clopidogrel fenntartó kezelés hatékonyan kivédi az elsődleges végpontban leirt szövődményeket a beavatkozást követő 30 napon belül, összehasonlítva a standard vérlemezke gátlási protokollal (az intervenció előtti 600 mg-os clopidogrel telítés és az azt követő 75 mg/nap clopidogrel terápia).

E.2.2

Secondary objectives of the trial

To assess safety of intensified loading with prasugrel in comparison to clopidogrel

Az erélyesebb prasugrel telítőadag biztonságosságának vizsgálata clopidogrelhez képest

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with biomarker negative unstable angina or patients with stable angina undergoing PCI

A betegek akkor vonhatók be a tanulmányba, ha minden alábbi kritériumnak
megfelelnek:
• Biomarker negativ, stabil vagy instabil angina prectorisban szenvedő betegek, akiknél perkutan koronaria intervenció javasolt

• írásos beleegyező nyilatkozat
• Fogamzóképes korú nők esetében terhességi teszt elvégzése kötelező

E.4

Principal exclusion criteria

Age>80 or <18,
biomarker positive acute coronary syndrome
contraindications to the investigational drugs (prasugrel, clopidogrel)

Életkor 80 év feletti vagy 18 év alatti
Biomarker pozitív akut koronária szindróma
Kontraindikáció a vizsgálati gyógyszerekkel szemben (prasugrel vagy klopidogrel)

E.5 End points

E.5.1

Primary end point(s)

Combined outcome of all-cause death, any myocardial infarction, stent thrombosis, urgent revascularization and stroke up to 30 days after randomization

Kombinált végpont, mely tartalmazza a
- bármilyen okból bekövetkező halál
- összes szívinfarktus
- stent thrombózis
- sürgős revaszkularizáció vagy
- stroke
valamelyikét 30 nappal a randomizálást követő intervallumban.

E.5.1.1

Timepoint(s) of evaluation of this end point

30-day after index PCI

30 nap

E.5.2

Secondary end point(s)

1. Bleeding complication BARC ≥2;
2. Non-CABG TIMI major and minor bleeding;
3. Incidence of peri-PCI MI Type 4a (according to Third Universal Definition of MI);
4) individual components of primary endpoint

1. BARC 2 vagy annál súlyosabb vérzéses esemény
2. Nem bypass műtéttel kapcsolatos major vagy minor vérzés a TIMI skálán
3. Perioperatív infarktus (4a típus a 3. konszenzus definíció szerint)
4. Az elsődleges végpont elemei

E.5.2.1

Timepoint(s) of evaluation of this end point

30-day after index PCI

30 nap

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

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

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

End of the trial is defined as data base lock

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:

900

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

1340

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

1990

F.4.2

For a multinational trial

F.4.2.2

In the whole clinical trial

2240

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)

After the study drug has been given, all patients will receive standard treatment as per local practice and equal to all other patients not participating in the study.

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

2017-04-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-04-25

P. End of Trial
P.	End of Trial Status	Ongoing

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