NCT00250380

The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)

The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)-A Prospective Multicenter Cohort Study-

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 583 (actual)
• Sponsor: Ministry of Health, Labour and Welfare, Japan · Other Government
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the clinically meaningful definition and prevalence of aspirin resistance based on data linking aspirin-dependent laboratory tests to recurrent vascular events in cardiovascular patients taking aspirin.

Detailed description

Primary Outcomes: The primary endpoint is the composite outcomes of cerebral infarction, transient ischemic attack, myocardial infarction, unstable angina, percutaneous coronary angiography, thromboembolism, and death caused by cardiovascular disease. Secondary Outcomes: Platelet aggregation induced by collagen and arachidonic acid, serum thromboxane B2, urine 11-dehydrothromboxane B2, platelet thrombus formation under flow conditions (sub-study only at the National Cardiovascular Center) The primary objective of this study is to determine the markers for aspirin resistance. To achieve this objective, platelet aggregation, serum thromboxane B2, and urine 11-dehydrothromboxane B2 are measured in patients receiving usual therapeutic doses of aspirin, who experienced acute coronary syndrome, cerebral infarction, or transient ischemic attack occurred in a period between the past 1 month and the past 2 years. This is a multi-center, prospective study.

Conditions

• Coronary Disease
• Cerebral Infarction
• Ischemic Attack, Transient

Timeline

• Start date: 2005-11-01
• Primary completion: 2010-06-01
• Completion: 2011-03-01
• First posted: 2005-11-08
• Last updated: 2011-12-13

Locations

23 sites across 1 country: Japan