An Asian Study to Assess the Properties and Profile of Ticagrelor in Patients With Stable Coronary Artery Disease

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Stable Coronary Artery Disease

Treatments: Drug: ticagrelor; Drug: clopidogrel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01118325

D5130C00065

Details and patient eligibility

About

The purpose of the study is to determine the drug characteristics of Ticagrelor, and to determine if 4 weeks treatment will reduce the blood clotting.

Enrollment: 146 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Any Percutaneous Coronary Intervention, more than 3 months prior to randomization
• Previous documented acute coronary syndrome (ACS), more than 3 months prior to randomisation
• Treatment with ASA

Exclusion criteria

• ACS, transient ischemic attack (TIA), or Stroke within the 3 months prior to randomisation
• Known concurrent disease of stroke or TIA with atrial fibrillation
• Persons who are being treated with blood clotting agents that cannot be stopped

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 3 patient groups

AZD6140 45 mg bd

Experimental group

Treatment:

Drug: ticagrelor

AZD6140 90 mg bd

Experimental group

Treatment:

Drug: ticagrelor

Clopidogrel 75 mg od

Active Comparator group

Treatment:

Drug: clopidogrel