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

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ClinicalTrials.gov Identifier: NCT00250380
Recruitment Status : Completed
First Posted : November 8, 2005
Last Update Posted : December 13, 2011
Sponsor:
Collaborator:
The National Institute of Biomedical Innovation
Information provided by (Responsible Party):
Toshiyuki Miyata, National Cerebral and Cardiovascular Center

Brief 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.

Condition or disease
Coronary Disease Cerebral Infarction Ischemic Attack, Transient

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.

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Study Type : Observational
Actual Enrollment : 583 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)-A Prospective Multicenter Cohort Study-
Study Start Date : November 2005
Actual Primary Completion Date : June 2010
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin




Biospecimen Retention:   Samples With DNA
whole blood, serum, urine


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
out-patient clinic
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00250380


Locations
Show Show 23 study locations
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
The National Institute of Biomedical Innovation
Investigators
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Principal Investigator: Toshiyuki Miyata, PhD National Cardiovascular Center, Research Institute,
Principal Investigator: Shigeki Miyata, MD National Cerebral and Cardiovascular Center
Principal Investigator: Kazuo Minematsu, MD National Cerebral and Cardiovascular Center
Principal Investigator: Masafumi Kitakaze, MD, PhD National Cerebral and Cardiovascular Center
Principal Investigator: Kazuyuki Nagatsuka, MD, PhD National Cerebral and Cardiovascular Center
Principal Investigator: Atsushi Kawamura, MD, PhD National Cerebral and Cardiovascular Center
Principal Investigator: Akiko Kada, MPH National Cerebral and Cardiovascular Center
Principal Investigator: Shinichiro Uchiyama, MD Tokyo Women's Medical University
Principal Investigator: Takehiko Nagao, MD, PhD Tokyo Metropolitan Ebara Hospital
Principal Investigator: Naohisa Hosomi, MD, PhD Kagawa University School of Medicine
Principal Investigator: Takemori Yamawaki, MD, PhD Nagoya City University Graduate School of Medical Science
Principal Investigator: Kazumi Kimura, MD, PhD Kawasaki Medical School
Principal Investigator: Kozue Saito, MD Nara Medical University
Principal Investigator: Hiroshi Nakane, MD National Fukuoka-Higashi Medical Center
Principal Investigator: Jyoji Nakagawara, MD Nakamura Memorial Hospital
Principal Investigator: Shinya Goto, MD Tokai University School of Medicine
Principal Investigator: Takaaki Isshiki, MD Teikyo University
Principal Investigator: Kazuo Kitagawa, MD Osaka University Graduate School of Medicine
Principal Investigator: Kazuomi Kario, MD Jichi Medical School
Principal Investigator: Hideo Wada, MD, PhD Mie University Graduate School of Medicine
Principal Investigator: Ken Nagata, MD Research Institute for Brain and Blood Vessels Akita
Principal Investigator: Koichi Kaikita, MD Kumamoto University Graduate School of Medicine
Principal Investigator: Keiji Tanaka, MD Nippon Medical School Hospital
Principal Investigator: Akira Hattori, MD Sado Hospital
Principal Investigator: Eisuke Furui, MD, PhD Kohnan Hospital
Principal Investigator: Yoshihiko Saito, MD, PhD Nara Medical University
Principal Investigator: Satoshi Ueno, MD Nara Medical University
Principal Investigator: Yasuo Katayama, MD Nippon Medical School Hospital
Principal Investigator: Takeo Abumiya, MD Hokkaido Neurosurgical Memorial Hospital
Principal Investigator: Masakatsu Nishikawa, MD Mie University Graduate School of Medicine
Principal Investigator: Shin Takiuchi, MD, PhD Higashi Takarazuka Satoh Hospital
Principal Investigator: Hideyuki Ohnishi, MD Ohnishi Neurological Center
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Responsible Party: Toshiyuki Miyata, Director, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT00250380    
Other Study ID Numbers: H17-CV(Seishu)-002
First Posted: November 8, 2005    Key Record Dates
Last Update Posted: December 13, 2011
Last Verified: December 2011
Keywords provided by Toshiyuki Miyata, National Cerebral and Cardiovascular Center:
Aspirin
Platelet Aggregation Inhibitors
Additional relevant MeSH terms:
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Cerebral Infarction
Ischemic Attack, Transient
Coronary Disease
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke