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

This study has been completed.
Sponsor:
Collaborator:
The National Institute of Biomedical Innovation
Information provided by (Responsible Party):
Toshiyuki Miyata, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier:
NCT00250380
First received: November 7, 2005
Last updated: December 12, 2011
Last verified: December 2011
  Purpose

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 Phase
Coronary Disease
Cerebral Infarction
Ischemic Attack, Transient
Phase 4

Study Type: Observational
Study Design: 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-

Resource links provided by NLM:


Further study details as provided by Ministry of Health, Labour and Welfare, Japan:

Biospecimen Retention:   Samples With DNA

whole blood, serum, urine


Enrollment: 583
Study Start Date: November 2005
Study Completion Date: March 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250380

Locations
Japan
National Fukuoka-Higashi Medical Center
Koga, Fukuoka, Japan, 8113195
Hokkaido Neurosurgical Memorial Hospital
Sapporo, Hokkaido, Japan, 0600022
Nakamura Memorial Hospital
Sapporo, Hokkaido, Japan, 0600061
Ohnishi Neurological Center
Akashi, Hyogo, Japan, 674-0064
Higashi Takarazuka Satoh Hospital
Takarazuka, Hyogo, Japan, 6650973
Kagawa University School of Medicine
Kida-gun, Kagawa, Japan, 7610793
Tokai University School of Medicine
Isehara, Kanagawa, Japan, 2591193
Mie University Graduate School of Medicine
Tsu, Mie, Japan, 5148507
Kohnan Hospital
Sendai, Miyagi, Japan, 9828523
Nara Medical University
Kashihara, Nara, Japan, 6348521
Sado Hospital
Sado, Niigata, Japan, 9521209
Kawasaki Medical School
Kurashiki, Okayama, Japan, 7010192
Osaka University Graduate School of Medicine
Suita, Osaka, Japan, 5650871
National Cardiovascular Center
Suita, Osaka, Japan, 5658565
National Hospital Organization Ureshino Medical Center
Fujitsu-gun, Saga, Japan, 8430393
Jichi Medical School
Kawachi-gun, Tochigi, Japan, 3290498
Research Institute for Brain and Blood Vessels Akita
Akita, Japan, 0100874
Kumamoto University Graduate School of Medicine
Kumamoto, Japan, 8608556
Nagoya City University Graduate School of Medical Sciences
Nagoya, Japan, 4678602
Tokyo Women's Medical University
Tokyo, Japan, 1628666
Tokyo Metropolitan Ebara Hospital
Tokyo, Japan, 1450065
Teikyo University
Tokyo, Japan, 1738606
Nippon Medical School Hospital
Tokyo, Japan, 1138603
Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
The National Institute of Biomedical Innovation
Investigators
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
  More Information

No publications provided

Responsible Party: Toshiyuki Miyata, Director, National Cerebral and Cardiovascular Center
ClinicalTrials.gov Identifier: NCT00250380     History of Changes
Other Study ID Numbers: H17-CV(Seishu)-002
Study First Received: November 7, 2005
Last Updated: December 12, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Ministry of Health, Labour and Welfare, Japan:
Aspirin
Platelet Aggregation Inhibitors

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Ischemic Attack, Transient
Coronary Disease
Coronary Artery Disease
Infarction
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Myocardial Ischemia
Heart Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Necrosis
Aspirin
Platelet Aggregation Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014