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Completed

NCT Number: NCT01294462

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)

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).

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Key information

Conditions

Acute Coronary Syndrome Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Myocardial Ischemia Percutaneous Coronary Intervention Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ichinomiya-shi, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

90 mg, oral dose twice daily

Other names: AZD6140

clopidogrel

Drug

75 mg, oral dose once daily

Other names: Plavix

Acetylsalicylic acid ASA

Drug

Low Dose ASA

Primary outcomes

  1. Major Bleeding

    Time frame: 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.

  2. Major Adverse Cardiac Events (MACE)

    Time frame: 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 outcomes

  1. Major and Minor Bleeding

    Time frame: 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.

  2. Composite of All-cause Mortality, MI or Stroke

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 11, 2011
Registry last updated
Jun 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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