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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

583 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-11-30

Study Completion Date

2011-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Coronary Disease Cerebral Infarction Ischemic Attack, Transient

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Aspirin Platelet Aggregation Inhibitors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Adult males or females who met the criteria listed below:

* Patients who had acute coronary syndrome, cerebral infarction (except cardioembolic stroke), or transient ischemic attack between past 28 days and the past 2 years
* patients who receive long-term aspirin therapy (at least 28 days)
* Patients who are \>=20 years of age
* Patients willing and able to give written informed consent

Exclusion Criteria

* Malignancy or suspected malignancy
* Patients who showed platelet counts less than 100,000/uL or more than 450,000/uL
* Congenital bleeding tendency
* Patients who receive other antiplatelet drugs or warfarin
* Patients with atrial fibrillation
* Patients who received surgical operation or catheter intervention within the past 2 weeks
* Patients who received anticoagulation drug therapy including heparin ( low-molecular weight heparin) and danaparoid.
* Patients with more than modified Rankin scale 4

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Toshiyuki Miyata

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Toshiyuki Miyata, PhD

Role: PRINCIPAL_INVESTIGATOR

National Cardiovascular Center, Research Institute,