Coronary DiseaseNCT00250380

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

An observational study of Coronary Disease and Cerebral Infarction, run by Ministry of Health, Labour and Welfare, Japan at 23 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Coronary Disease, Cerebral Infarction, Ischemic Attack, Transient
How many people: 583 participants
Where: 23 sitesJapan
Study dates: Nov 2005to Mar 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: out-patient clinic

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

23 sites in 1 country.

City, postcode or hospital

23 sites in 1 country

Japan23 sites

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

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About this study

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

Read the 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.

Conditions: Coronary Disease, Cerebral Infarction, Ischemic Attack, Transient
Keywords: Aspirin, Platelet Aggregation Inhibitors
Medical subject headings: Coronary Disease, Cerebral Infarction, Ischemic Attack, Transient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2005Mar 2011

First posted8 Nov 2005 (estimated)
Study startNov 2005
Primary completionJun 2010
Study completionMar 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Coronary DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 583 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00250380
Sponsor's protocol ID: H17-CV(Seishu)-002
Status last verified: Dec 2011
First submitted: 7 Nov 2005
Last updated: 13 Dec 2011
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Study on Profile and Genetic Factors of Aspirin Resistance (ProGEAR Study)-A Prospective Multicenter Cohort Study-
ClinicalTrials.gov ID: NCT00250380
Acronym / sponsor ID: H17-CV(Seishu)-002
Conditions: Coronary Disease, Cerebral Infarction, Ischemic Attack, Transient
Keywords: Aspirin, Platelet Aggregation Inhibitors
Study type: Observational
Recruitment status: Completed
Enrolment: 583 participants (actual)
Lead sponsor: Ministry of Health, Labour and Welfare, JapanOther government
Collaborators: National Institute of Biomedical Innovation
Study start: Nov 2005
Primary completion: Jun 2010 (actual)
Study completion: Mar 2011 (actual)
First posted: 8 Nov 2005 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: out-patient clinic

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Not reported in the source record.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2011.

Related trials for Coronary Disease

Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Toshiyuki Miyata, PhD principal investigator

National Cardiovascular Center, Research Institute,

Shigeki Miyata, MD principal investigator

National Cerebral and Cardiovascular Center, Japan

Kazuo Minematsu, MD principal investigator

National Cerebral and Cardiovascular Center, Japan

23 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Disease and Cerebral Infarction, run by Ministry of Health, Labour and Welfare, Japan at 23 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00250380.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2011.