Clinical trial NCT00250380: The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)
Official title: The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)-A Prospective Multicenter Cohort Study-
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Cerebral Infarction
Ischemic Attack, Transient
Keywords: Aspirin
Platelet Aggregation Inhibitors
Lead sponsor: Ministry of Health, Labour and Welfare, Japan
Sponsor class: OTHER_GOV
Collaborators: name: The National Institute of Biomedical Innovation
First posted: 2005-11-08
Enrollment: 583
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: out-patient clinic

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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Koga
country: Japan
facility: National Fukuoka-Higashi Medical Center
state: Fukuoka
city: Sapporo
country: Japan
facility: Hokkaido Neurosurgical Memorial Hospital
state: Hokkaido
city: Sapporo
country: Japan
facility: Nakamura Memorial Hospital
state: Hokkaido
city: Akashi
country: Japan
facility: Ohnishi Neurological Center
state: Hyogo
city: Takarazuka
country: Japan
facility: Higashi Takarazuka Satoh Hospital
state: Hyogo
city: Kida-gun
country: Japan
facility: Kagawa University School of Medicine
state: Kagawa
city: Isehara
country: Japan
facility: Tokai University School of Medicine
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Graduate School of Medicine
state: Mie
city: Sendai
country: Japan
facility: Kohnan Hospital
state: Miyagi
city: Kashihara
country: Japan
facility: Nara Medical University
state: Nara
city: Sado
country: Japan
facility: Sado Hospital
state: Niigata
city: Kurashiki
country: Japan
facility: Kawasaki Medical School
state: Okayama
city: Suita
country: Japan
facility: Osaka University Graduate School of Medicine
state: Osaka
city: Suita
country: Japan
facility: National Cardiovascular Center
state: Osaka
city: Fujitsu-gun
country: Japan
facility: National Hospital Organization Ureshino Medical Center
state: Saga
city: Kawachi-gun
country: Japan
facility: Jichi Medical School
state: Tochigi
city: Akita
country: Japan
facility: Research Institute for Brain and Blood Vessels Akita
city: Kumamoto
country: Japan
facility: Kumamoto University Graduate School of Medicine
city: Nagoya
country: Japan
facility: Nagoya City University Graduate School of Medical Sciences
city: Tokyo
country: Japan
facility: Nippon Medical School Hospital
city: Tokyo
country: Japan
facility: Tokyo Metropolitan Ebara Hospital
city: Tokyo
country: Japan
facility: Tokyo Women's Medical University
city: Tokyo
country: Japan
facility: Teikyo University
Study officials:
affiliation: National Cardiovascular Center, Research Institute,
name: Toshiyuki Miyata, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Shigeki Miyata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Kazuo Minematsu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Masafumi Kitakaze, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Kazuyuki Nagatsuka, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Atsushi Kawamura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Cerebral and Cardiovascular Center, Japan
name: Akiko Kada, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo Women's Medical University
name: Shinichiro Uchiyama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokyo Metropolitan Ebara Hospital
name: Takehiko Nagao, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kagawa University School of Medicine
name: Naohisa Hosomi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nagoya City University Graduate School of Medical Science
name: Takemori Yamawaki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kawasaki Medical School
name: Kazumi Kimura, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nara Medical University
name: Kozue Saito, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: National Fukuoka-Higashi Medical Center
name: Hiroshi Nakane, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nakamura Memorial Hospital
name: Jyoji Nakagawara, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tokai University School of Medicine
name: Shinya Goto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Teikyo University
name: Takaaki Isshiki, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Osaka University Graduate School of Medicine
name: Kazuo Kitagawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jichi Medical School
name: Kazuomi Kario, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mie University Graduate School of Medicine
name: Hideo Wada, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Institute for Brain and Blood Vessels Akita
name: Ken Nagata, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kumamoto University Graduate School of Medicine
name: Koichi Kaikita, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nippon Medical School Hospital
name: Keiji Tanaka, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sado Hospital
name: Akira Hattori, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kohnan Hospital
name: Eisuke Furui, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nara Medical University
name: Yoshihiko Saito, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nara Medical University
name: Satoshi Ueno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nippon Medical School Hospital
name: Yasuo Katayama, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hokkaido Neurosurgical Memorial Hospital
name: Takeo Abumiya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mie University Graduate School of Medicine
name: Masakatsu Nishikawa, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Higashi Takarazuka Satoh Hospital
name: Shin Takiuchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ohnishi Neurological Center
name: Hideyuki Ohnishi, MD
role: PRINCIPAL_INVESTIGATOR
References: