Phase 3
N=801
Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Acute Coronary Syndrome · Percutaneous Coronary Intervention
Bottom Line
View on ClinicalTrials.gov: NCT01294462 ↗Enrolled (actual)
801
Serious AEs
26.6%
Results posted
May 2014
Primary outcome: Primary: Major Bleeding — 11.2; 8.4 Percent probability
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ticagrelor (Drug); Clopidogrel (Drug); Acetylsalicylic acid ASA (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Bleeding |
11.2; 8.4 | — |
| PRIMARY Major Adverse Cardiac Events (MACE) |
10.2; 8.1 | — |
| SECONDARY Major and Minor Bleeding |
26.8; 16.2 | — |
| SECONDARY Composite of All-cause Mortality, MI or Stroke |
10.5; 8.1 | — |
Summary
The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).
Eligibility Criteria
Inclusion Criteria
- Provision of signed informed consent
- Index event of non-ST or ST segment elevation ACS
Exclusion Criteria
- Index event is an acute complication of percutaneous coronary intervention
- Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
- Oral anticoagulation therapy that cannot be stopped
- The conditions associated with increased risk of bradycardiac events
Data sourced from ClinicalTrials.gov (NCT01294462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.