ISAR-REACT 5: Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome

Sponsor

Deutsches Herzzentrum Muenchen (Other)

Overall Status

Unknown status

CT.gov ID

NCT01944800

Collaborator

Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK) (Other)

4,000

Enrollment

Locations

Arms

92.5

Anticipated Duration (Months)

210.5

Patients Per Site

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Aim of the randomized, open-label, multicenter ISAR-REACT 5 trial is to assess whether ticagrelor is superior to prasugrel in patients with acute coronary syndrome and planned invasive strategy in terms of clinical outcomes.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome (ACS)	Drug: Ticagrelor Drug: Prasugrel	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

4000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome - Intracoronary Stenting and Antithrombotic Regimen: Rapid Early Action for Coronary Treatment (ISAR-REACT) 5

Actual Study Start Date :

Sep 15, 2013

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Jun 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ticagrelor	Drug: Ticagrelor Loading dose of 180 mg, followed by maintenance dose of 180 mg per day Other Names: Brilique
Active Comparator: Prasugrel	Drug: Prasugrel Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/> 75 years or < 60 kg Other Names: Efient

Arm

Intervention/Treatment

Experimental: Ticagrelor

Drug: Ticagrelor

Loading dose of 180 mg, followed by maintenance dose of 180 mg per day

Other Names:

Brilique

Active Comparator: Prasugrel

Drug: Prasugrel

Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/> 75 years or < 60 kg

Other Names:

Efient

Outcome Measures

Primary Outcome Measures

Composite of death, myocardial infarction or stroke [12 months]

Secondary Outcome Measures

Bleeding [12 months]
Bleeding according to BARC
Mortality [12 months]
Death for any cause
Stroke [12 months]
Stroke
Myocardial Infarction [12 months]
Stent Thrombosis [12 months]
Stent thrombosis according to ARC

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Major Inclusion Criteria:

Hospitalization for an acute coronary syndrome (ST-segment elevation myocardial infarction, non-ST-segment elevation myocardial infarction or unstable angina pectoris) with planned invasive strategy

Major Exclusion Criteria:

intolerance of or allergy to ticagrelor or prasugrel
history of any stroke, transient ischemic attack or intracranial bleeding
known intracranial neoplasm, intracranial arteriovenous malformation or intracranial aneurysm
active bleeding, clinical findings, that in the judgement of the investigator are associated with an increased risk of bleeding
fibrin-specific fibrinolytic therapy less than 24 h before randomization, non-fibrin-specific fibrinolytic therapy less than 48 h before randomization
known platelet count < 100.000/μL at the time of screening
known anemia (hemoglobin <10 g/dL) at the time of screening
oral anticoagulation that cannot be safely discontinued for the duration of the study
INR known to be greater than 1.5 at the time of screening
chronic renal insufficiency requiring dialysis
moderate or severe hepatic dysfunction (Child Pugh B or C)
increased risk of bradycardia events (Sick Sinus, AV block grade II or III, bradycardia-induced syncope)
index event is an acute complication (< 30 days) of PCI
concomitant medical illness that in the opinion of the investigator is associated with a life expectancy < 1 year
concomitant oral or i.v. therapy with strong CYP3A Inhibitors (e.g. ketoconazole, itraconazole, voriconazole, telithromycin, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, grapefruit juice > 1 L/d), CYP3A substrates with narrow therapeutic indices (e.g. cyclosporine, quinidine), or strong CYP3A inducers (e.g. rifampin/rifampicin, phenytoin, carbamazepine, dexamethason, phenobarbital ) that cannot be safely discontinued
≥1 doses of ticagrelor or prasugrel within 5 days before randomisation
no written informed consent
participation in another investigational drug study
previous enrolment in this study
for women of childbearing potential no negative pregnancy test and no agree to use reliable method of birth control during the study
Pregnancy, giving birth within the last 90 days, or lactation
inability to cooperate with protocol requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitäts-Herzzentrum Freiburg/ Bad Krozingen	Bad Krozingen	Baden-Württemberg	Germany	79189
2	Universitäts-Klinikum Heidelberg	Heidelberg	Baden-Württemberg	Germany	69120
3	Universitätsklinikum Mannheim	Mannheim	Baden-Württemberg	Germany	68167
4	Universitätsklinikum Ulm	Ulm	Baden-Württemberg	Germany	89081
5	Klinikum Landkreis Erding	Erding	Bavaria	Germany	85435
6	Deutsches Herzzentrum Munich	München	Bavaria	Germany	80636
7	Klinikum rechts der Isar, 1. Medizinische Klinik und Poliklinik	München	Bavaria	Germany	81675
8	Klinikum Neuperlach	München	Bavaria	Germany	81737
9	Universitätsklinikum Regensburg	Regensburg	Bavaria	Germany	93042
10	Klinikum Traunstein	Traunstein	Bavaria	Germany	83278
11	Kerckhoff-Klinik GmbH, Abteilung für Kardiologie	Bad Nauheim	Hessen	Germany	61231
12	Universitätsmedizin Göttingen, Herzzentrum	Göttingen	Niedersachsen	Germany	37099
13	Herzzentrum Wuppertal	Wuppertal	Nordrhein-Westfalen	Germany	42117
14	Segeberger Kliniken GmbH	Bad Segeberg	Schleswig-Holstein	Germany	23795
15	Universitätsklinikum Schleswig-Holstein, Klinik für Innere Medizin III, Campus Kiel	Kiel	Schleswig-Holstein	Germany	24105
16	Charité - Universitätsmedizin Berlin, Campus Benjamin Franklin	Berlin		Germany	12203
17	Charité Universitätsmedizin Berlin, Campus Virchow-Klinik	Berlin		Germany	13353
18	Careggi University Hospital, Invasive Cardiology Division	Firenze		Italy	50141
19	Spaziani Hospital Frosinone	Frosinone		Italy	03100