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

Coronary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00250380
• Other study ID #: H17-CV(Seishu)-002
• Status: Completed
• Phase: Phase 4
• First received: November 7, 2005
• Last updated: December 12, 2011
• Start date: November 2005
• Est. completion date: March 2011

Study information

• Verified date: December 2011
• Source: Ministry of Health, Labour and Welfare, Japan
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: March 2011
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Infarction
• Coronary Artery Disease
• Coronary Disease
• Ischemic Attack, Transient

Locations

Country	Name	City	State
Japan	Ohnishi Neurological Center	Akashi	Hyogo
Japan	Research Institute for Brain and Blood Vessels Akita	Akita
Japan	National Hospital Organization Ureshino Medical Center	Fujitsu-gun	Saga
Japan	Tokai University School of Medicine	Isehara	Kanagawa
Japan	Nara Medical University	Kashihara	Nara
Japan	Jichi Medical School	Kawachi-gun	Tochigi
Japan	Kagawa University School of Medicine	Kida-gun	Kagawa
Japan	National Fukuoka-Higashi Medical Center	Koga	Fukuoka
Japan	Kumamoto University Graduate School of Medicine	Kumamoto
Japan	Kawasaki Medical School	Kurashiki	Okayama
Japan	Nagoya City University Graduate School of Medical Sciences	Nagoya
Japan	Sado Hospital	Sado	Niigata
Japan	Hokkaido Neurosurgical Memorial Hospital	Sapporo	Hokkaido
Japan	Nakamura Memorial Hospital	Sapporo	Hokkaido
Japan	Kohnan Hospital	Sendai	Miyagi
Japan	National Cardiovascular Center	Suita	Osaka
Japan	Osaka University Graduate School of Medicine	Suita	Osaka
Japan	Higashi Takarazuka Satoh Hospital	Takarazuka	Hyogo
Japan	Nippon Medical School Hospital	Tokyo
Japan	Teikyo University	Tokyo
Japan	Tokyo Metropolitan Ebara Hospital	Tokyo
Japan	Tokyo Women's Medical University	Tokyo
Japan	Mie University Graduate School of Medicine	Tsu	Mie

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Labour and Welfare, Japan	The National Institute of Biomedical Innovation

Country where clinical trial is conducted

Japan,