Prospective, Randomized Trial of Ticagrelor Versus Prasugrel in Patients With Acute Coronary Syndrome

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Acute Coronary Syndrome (ACS)

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Prasugrel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of death, myocardial infarction or stroke |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding | Bleeding according to BARC | 12 months | 
| Mortality | Death for any cause | 12 months | 
| Stroke | Stroke | 12 months | 
| Myocardial Infarction |  | 12 months | 
| Stent Thrombosis | Stent thrombosis according to ARC | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ticagrelor, Prasugrel, Acute coronary syndrome, Percutaneous coronary intervention