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

NCT00250380 | Completed DMC

• 1 other identifier: H17-CV(Seishu)-002
• Study Type: observational
• Target: 583
• Locations: 1 country
• Sites: 23

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.

Conditions

Coronary Disease; Cerebral Infarction; Ischemic Attack, Transient

Keywords

Aspirin; Platelet Aggregation Inhibitors

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

out-patient clinic

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ministry of Health, Labour and Welfare, Japan: lead
• The National Institute of Biomedical Innovation: collaborator

Study Sites (23)

Research Institute for Brain and Blood Vessels Akita

Akita, Akita, 0100874, Japan

Location

National Fukuoka-Higashi Medical Center

Koga, Fukuoka, 8113195, Japan

Location

Hokkaido Neurosurgical Memorial Hospital

Sapporo, Hokkaido, 0600022, Japan

Location

Nakamura Memorial Hospital

Sapporo, Hokkaido, 0600061, Japan

Location

Ohnishi Neurological Center

Akashi, Hyōgo, 674-0064, Japan

Location

Higashi Takarazuka Satoh Hospital

Takarazuka, Hyōgo, 6650973, Japan

Location

Kagawa University School of Medicine

Kida-gun, Kagawa-ken, 7610793, Japan

Location

Tokai University School of Medicine

Isehara, Kanagawa, 2591193, Japan

Location

Kumamoto University Graduate School of Medicine

Kumamoto, Kumamoto, 8608556, Japan

Location

Mie University Graduate School of Medicine

Tsu, Mie-ken, 5148507, Japan

Location

Kohnan Hospital

Sendai, Miyagi, 9828523, Japan

Location

Nagoya City University Graduate School of Medical Sciences

Nagoya, Nagoya, 4678602, Japan

Location

Nara Medical University

Kashihara, Nara, 6348521, Japan

Location

Sado Hospital

Sado, Niigata, 9521209, Japan

Location

Kawasaki Medical School

Kurashiki, Okayama-ken, 7010192, Japan

Location

Osaka University Graduate School of Medicine

Suita, Osaka, 5650871, Japan

Location

National Cardiovascular Center

Suita, Osaka, 5658565, Japan

Location

National Hospital Organization Ureshino Medical Center

Fujitsu-gun, Saga-ken, 8430393, Japan

Location

Jichi Medical School

Kawachi-gun, Tochigi, 3290498, Japan

Location

Nippon Medical School Hospital

Tokyo, Tokyo, 1138603, Japan

Location

Tokyo Metropolitan Ebara Hospital

Tokyo, Tokyo, 1450065, Japan

Location

Tokyo Women's Medical University

Tokyo, Tokyo, 1628666, Japan

Location

Teikyo University

Tokyo, Tokyo, 1738606, Japan

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, urine

MeSH Terms

Conditions

Coronary Disease; Cerebral Infarction; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Infarction; Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Toshiyuki Miyata, PhD

  National Cardiovascular Center, Research Institute,

  PRINCIPAL INVESTIGATOR

• Shigeki Miyata, MD

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

• Kazuo Minematsu, MD

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

• Masafumi Kitakaze, MD, PhD

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

• Kazuyuki Nagatsuka, MD, PhD

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

• Atsushi Kawamura, MD, PhD

  National Cerebral and Cardiovascular Center, Japan

  PRINCIPAL INVESTIGATOR

• Akiko Kada, MPH

  National Cerebral and Cardiovascular Center, Japan

  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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 7, 2005
• First Posted: November 8, 2005
• Study Start: November 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: March 1, 2011
• Last Updated: December 13, 2011

Record last verified: 2011-12

Locations

JP (23)