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)

Phase 3

Completed

• Conditions: Acute Coronary Syndrome; Percutaneous Coronary Intervention
• Interventions: Drug: Clopidogrel; Drug: Ticagrelor; Drug: Acetylsalicylic acid ASA

• Registration Number: NCT01294462
• Lead Sponsor: AstraZeneca

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-10
• Study First Submitted QC: 2011-02-10
• Study First Posted: 2011-02-11
• Disposition First Submitted: 2011-02-23
• Disposition First Submitted QC: 2011-03-15
• Disposition First Posted: 2011-03-25
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Results First Submitted: 2013-07-10
• Results First Submitted QC: 2014-03-31
• Status Verified: 2014-05
• Results First Posted: 2014-05-02
• Last Update Submitted: 2014-06-18
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 801

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Acetylsalicylic acid ASA	Ticagrelor (AZD6140)
2	Clopidogrel	Clopidogrel
2	Acetylsalicylic acid ASA	Clopidogrel
1	Ticagrelor	Ticagrelor (AZD6140)

Primary Outcome Measures

Name	Time	Method
Major Bleeding	Ongoing up to12 months	Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Major Adverse Cardiac Events (MACE)	Ongoing up to 12 months	Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.

Secondary Outcome Measures

Name	Time	Method
Major and Minor Bleeding	Ongoing up to12 months	Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Composite of All-cause Mortality, MI or Stroke	Ongoing up to 12 months	Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taipei, Taiwan