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

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

Study Overview

• Status: Completed
• Conditions: Coronary Disease; Ischemic Attack, Transient; Cerebral Infarction

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.

• Study Type: Observational
• Enrollment (Actual): 583

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

out-patient clinic

Description

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 Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Ministry of Health, Labour and Welfare, Japan
• Collaborators: 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

Study record dates

Study Major Dates

• Study Start: November 1, 2005
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): March 1, 2011

Study Registration Dates

• First Submitted: November 7, 2005
• First Submitted That Met QC Criteria: November 7, 2005
• First Posted (Estimate): November 8, 2005

Study Record Updates

• Last Update Posted (Estimate): December 13, 2011
• Last Update Submitted That Met QC Criteria: December 12, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: Aspirin; Platelet Aggregation Inhibitors
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Brain Infarction; Infarction; Coronary Disease; Ischemic Attack, Transient; Cerebral Infarction
• Other Study ID Numbers: H17-CV(Seishu)-002