TRIAL OF TICAGRELOR VERSUS PRASUGREL IN PATIENTS WITH ACUTE CORONARY SYNDROME

PROSPECTIVE, RANDOMIZED TRIAL OF TICAGRELOR VERSUS PRASUGREL IN PATIENTS WITH ACUTE CORONARY SYNDROME - ISAR-REACT 5

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-002272-40-DE

Enrollment

3800

Registered

2013-07-08

Start date

2013-08-26

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with acute coronary syndromes (ACS) – including patients with unstable angina, non-ST-segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI) MedDRA version: 20.0 Level: PT Classification code 10051592 Term: Acute coronary syndrome System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: Brilique Product Name: Brilique Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ticagrelor Other descriptive name: TICAGRELOR Concentration unit: mg milligram(s) Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients presenting with acute coronary syndrome and planned invasive strategy Informed, written consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2000

Exclusion criteria

Exclusion criteria: Active Bleeding History of stroke or TIA Chronic renal insufficiency requiring dialysis Moderate to severe hepatic dysfunction Need for oral anticoagulation

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Composite of death, myocardial infarction or stroke at 12 months after randomisation;Timepoint(s) of evaluation of this end point: 30 days 6-months 12-months 36-months ;Main Objective: The objective of this study is to test the hypothesis that ticagrelor is superior to prasugrel regarding the composite of death, myocardial infarction or stroke at 12 months after randomisation. ;Secondary Objective: Safety Endpoint: The incidence of bleeding (BARC class 3-5) Secondary Endpoints: The incidence of the individual components of the primary endpoint The incidence of stent thrombosis (ARC definite or probable)	—

Measure

Time frame

Primary end point(s): Composite of death, myocardial infarction or stroke at 12 months after randomisation;Timepoint(s) of evaluation of this end point: 30 days 6-months 12-months 36-months ;Main Objective: The objective of this study is to test the hypothesis that ticagrelor is superior to prasugrel regarding the composite of death, myocardial infarction or stroke at 12 months after randomisation. ;Secondary Objective: Safety Endpoint: The incidence of bleeding (BARC class 3-5) Secondary Endpoints: The incidence of the individual components of the primary endpoint The incidence of stent thrombosis (ARC definite or probable)

—

Secondary

Measure	Time frame
Secondary end point(s): Safety endpoint: Bleeding according to BARC criteria (BARC class 3-5) The individual components of the primary endpoint Stent thrombosis according to ARC criteria (definite or probable) ;Timepoint(s) of evaluation of this end point: 30 days 6-months 12-months	—

Countries

Germany, Italy

Contacts

Public ContactISAResearch Center

Deutsches Herzzentrum München, ISAResearch Center

schuster@dhm.mhn.de+498912181528

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026