Clinical Trials Register

Summary
EudraCT Number:	2018-002161-19
Sponsor's Protocol Code Number:	13062017-23-1
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-06-27
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

Czechia - SUKL

A.2

EudraCT number

2018-002161-19

A.3

Full title of the trial

Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction

Duální protidestičková léčba pacientů s akutním infarktem myokardu v kardiogenním šoku

A.3.1

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

Dual Antiplatelet Therapy For Shock Patients With Acute Myocardial Infarction

A.3.2

Name or abbreviated title of the trial where available

DAPT-SHOCK-AMI study (PRAGUE-23)

A.4.1

Sponsor's protocol code number

13062017-23-1

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	Fakultní nemocnice Královské Vinohrady
B.1.3.4	Country	Czechia
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	Prof. MUDr. Zuzana Motovska, Ph.D. FESC.
B.4.2	Country	Czechia
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fakultní nemocnice Královské Vinohrady
B.5.2	Functional name of contact point	Prof. MUDr. Zuzana Motovska, Ph.D.
B.5.3	Address:
B.5.3.1	Street Address	Srobarova 1150/50
B.5.3.2	Town/ city	Prague
B.5.3.3	Post code	100 34
B.5.3.4	Country	Czechia
B.5.4	Telephone number	00420267163760
B.5.6	E-mail	motovska.zuzana@gmail.com

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	Kengrexal
D.2.1.1.2	Name of the Marketing Authorisation holder	Chiesi Farmaceutici S.p.A.
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	Powder for concentrate for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Cangrelor tetrasodium
D.3.9.3	Other descriptive name	CANGRELOR TETRASODIUM
D.3.9.4	EV Substance Code	SUB182388
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	50
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	Brilique
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca AB
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	Ticagrelor
D.3.9.3	Other descriptive name	TICAGRELOR
D.3.9.4	EV Substance Code	SUB30898
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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Powder for concentrate for solution for injection/infusion
D.8.4	Route of administration of the placebo	Intravenous use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Cardiogenic shock in acute myocardial infarction

Kardiogenní šok při akutním infarktu myokardu

E.1.1.1

Medical condition in easily understood language

Myocardial infarction

Infarkt myokardu

E.1.1.2

Therapeutic area

Diseases [C] - Cardiovascular Diseases [C14]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Comparison of parenteral cangrelor to the recommended ticagrelor treatment in ADP-induced platelet aggregation.
Comparison of parenteral cangrelor to the recommended ticagrelor treatment comparing an occurence of large cariovascular events in patients with cardiogenic shock in acute myocardial infarction.

Srovnání vlivu parenterálního Cangreloru s doporučovanou léčbou Ticagrelorem na adenozindifosfátem (ADP) aktivovanou agregaci destiček.
Srovnání vlivu parenterálního Cangreloru s doporučovanou léčbou Ticagrelorem na výskyt velkých kardiovaskulárních příhod u pacientů s akutním infarktem myokardu iniciálně v kardiogenním šoku.

E.2.2

Secondary objectives of the trial

Occurence of death/ Myocardial infarction/ urgent myocardial revasularization/ stroke/ major bleeding as per BARC definition

Smrt/Infarkt myokardu/Urgentní revaskularizace infarktové tepny/CMP/Velké krvácení dle definice BARC

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

1. MRI sub-study, 21.4.2020, version 1.0.
Objectives: Determination of the prognostic significance of individual measured parameters of ventricular morphology/function, hemodynamics and structural myocardial involvement in the prediction of hospitalization mortality and clinically significant complications at baseline and during 12-month follow up in patients with cardiogenic shock complicating heart attack. At the same time, the values of MR examinations will be compared with cardiac markers and echocardiography.

2. The Platelet Reactivity Sub-study (laboratory sub-study), described in the protocol amendment 2 from 7.7.2021
Objectives: Examination of the effectiveness of antiplatelet therapy by the determination of VASP protein phosphorylation via flow cytometry.

1. MRI podstudie, 21.4.2020, verze 1.0.
Cíle: Stanovení prognostického významu jednotlivých měřených
parametrů komorové morfologie/funkce, hemodynamiky a
strukturálního postižení myokardu v predikci úmrtnosti při hospitalizaci
a klinicky významných komplikací na počátku a během 12měsíčního
sledování u pacientů s kardiogenním šokem komplikujícím infarkt
myokardu. Současně budou porovnávány hodnoty MR vyšetření se
srdečními markery a echokardiografií.
2. Podstudie reaktivity krevních destiček (laboratorní podstudie),
popsaná v amendmentu protokolu 2 ze dne 7.7.2021
Cíle: Zkoumání účinnosti protidestičkové terapie stanovením fosforylace
proteinu VASP pomocí průtokové cytometrie.

E.3

Principal inclusion criteria

1. Age more than 18
2. Acute myocardial infarction as per ESC/ACC/AHA23 indicated to emergency percutaneous coronary intervention (primary PCI strategy)
3. Cardiogenic shock resulting from acute myocardial infarction in admission (occurence of two or more of the following criteria):
- systolic blood preassure < 90mmHg
- necessity of vasopressor and/or inotropes use
- signs of organ perfusion - cyanosis, cold body extremities, unconsciousness, congestive heart failure
4. Signed informed consent

1.Věk nad 18 let
2.Akutní infarkt myokardu dle definice ESC/ACC/AHA23 indikován k emergentní perkutánní koronární intervenci (primární PCI strategii)
3.Kardiogenní šok při přijetí, který je důsledkem akutního infarktu myokardu (přítomnost ≥ 2 níže uvedených kritérií)
-sTK < 90mmHg
-nutnost léčby vazopresory a/nebo inotropiky
-přítomnost znaků orgánové hypoperfuze – cyanóza, chladná akra, porucha vědomí, kongestivní srdeční selhání
4.Podepsání informovaného souhlasu

E.4

Principal exclusion criteria

1. Contraindication to anti-platelet ticagrelor/cangrelor treatment
- recent (< 6 months) major bleeding
-recent (< 1 month) major surgery/injury
-intracranial bleeding in anamnesis
-stroke/TIA in anamnesis
-Ticagrelor/Cangrelor intolerance
-serious liver indeficiency
-concomitant use of CYP3A4 inhibitor (eg. ketokonazole, clarithromycin, nefazodon, ritonavir, atazanavir)
2. Oral use of P2Y12 inhibitor before admission (Clopidogrel ≥ 300mg, Ticagrelor 180 mg, Prasugrel 60 mg)
3. Necessity of concomitant chronic anticoagulant treatment for atrial fibrillation, artificial valve, tromboembolism etc.)

1. Kontraindikace protidestičkové léčby Ticagrelorem/Cangrelorem
-recentní (< 6 měsíců) velké krvácení
-recentní (< 1 měsíc) velká operace/úraz
-anamnéza intrakraniálního krvácení
-anamnéza CMP/TIA
-známá intolerance Ticagreloru/Cangreloru
-závažná porucha funkce jater
-souběžné podávání silných inhibitorů CYP3A4 (např. ketokonazolem, klarithromycinem, nefazodonem, ritonavirem a atazanavirem)
2. Podání nasycovací dávky perorálního inhibitoru P2Y12 před přijetím (Clopidogrel ≥ 300mg, Ticagrelor 180 mg, Prasugrel 60 mg)
3. Nutnost současné chronické antikoagulační léčby z indikace fibrilace síní, umělé chlopně. tromboembolické nemoci apod.

E.5 End points

E.5.1

Primary end point(s)

E.5.1.1

Timepoint(s) of evaluation of this end point

End of the trial.

E.5.2

Secondary end point(s)

Occurence of death/ Myocardial infarction/ urgent myocardial revasularization/ stroke/ major bleeding as per BARC definition

Smrt/Infarkt myokardu/Urgentní revaskularizace infarktové tepny/CMP/Velké krvácení dle definice BARC

E.5.2.1

Timepoint(s) of evaluation of this end point

End of the trial.

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

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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

Yes

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

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

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

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:

275

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

275

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

Information not present in EudraCT

F.3.3.3

Pregnant women

Information not present in EudraCT

F.3.3.4

Nursing women

Information not present in EudraCT

F.3.3.5

Emergency situation

Yes

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Considering the followed diagnosis it may happen that there will be unconscious subjects included. A need of witness is described in the protocol.

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

450

F.4.2

For a multinational trial

F.4.2.1

In the EEA

550

F.4.2.2

In the whole clinical trial

550

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)

The trial follows a common clinical practice, after the subject´s participationthe the treatment will continue in the same way .

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

2018-06-25

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-06-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2025-01-17

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