Skip to main content
OpenTrials
Completed

NCT Number: NCT00250380

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Institute for Brain and Blood Vessels Akita, Akita, Japan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Sponsors and collaborators

Lead sponsor

Ministry of Health, Labour and Welfare, Japan

Other Gov

Collaborators

  • The National Institute of Biomedical Innovation

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2010
Study completion
2011
First posted
Nov 8, 2005
Registry last updated
Dec 13, 2011

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.

Published trials that share one or more normalized conditions with this study.