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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00250380
Other study ID # H17-CV(Seishu)-002
Secondary ID
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


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, 

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