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) - Full Text View

Purpose

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).

Condition	Intervention	Phase
Acute Coronary Syndrome Percutaneous Coronary Intervention	Drug: Ticagrelor Drug: Clopidogrel Drug: Acetylsalicylic acid ASA	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Aspirin Clopidogrel bisulfate Ticagrelor

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Safety of Ticagrelor (AZD6140) compared to Clopidogrel by measuring the time to first occurrence of any total major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)) [ Time Frame: Ongoing up to12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety of Ticagrelor (AZD6140) compared to Clopidogrel by measuring the total number of bleeding events (including major, minor and minimal bleedings) [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing the time to first occurrence of any event from the composite of all-cause mortality, MI or stroke [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: No ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of Adverse events (AEs) [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of laboratory values [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of physical examination [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of electrocardiography (12-lead ECG) [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of Holter ECG [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]
Effect of Ticagrelor (AZD6140) compared to Clopidogrel by assessing number of vital signs (heart rate and blood pressure (systolic and diastolic)). [ Time Frame: Ongoing up to 12 months ] [ Designated as safety issue: Yes ]

Enrollment:	800
Study Start Date:	February 2011
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Ticagrelor (AZD6140)	Drug: Ticagrelor 90 mg, oral dose twice daily Other Name: AZD6140 Drug: Acetylsalicylic acid ASA Low Dose ASA
Active Comparator: 2 Clopidogrel	Drug: Clopidogrel 75 mg, oral dose once daily Other Name: Plavix Drug: Acetylsalicylic acid ASA Low Dose ASA

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01294462

Show 94 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Judith Hsia, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT01294462 History of Changes
Other Study ID Numbers:	D5130C00027
Study First Received:	February 10, 2011
Last Updated:	August 17, 2012
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency Korea: Food and Drug Administration Taiwan: Department of Health

Keywords provided by AstraZeneca:

acute coronary syndrome
coronary disease
coronary artery disease

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Aspirin
Clopidogrel
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013