Atherothrombosis Clinical Trial
— PARes-IIOfficial title:
Pharmacogenomics of Antiplatelet Response - II
Verified date | September 2014 |
Source | Johns Hopkins University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This clinical trial is examining the effect of 4-week aspirin therapy on platelet transcriptome in persons at high-risk for myocardial infarction or stroke due to family history of early-onset coronary artery disease.
Status | Completed |
Enrollment | 33 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 45 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Participants from the GeneSTAR cohort - Unaffected with no overt coronary artery disease or serious vascular event (stroke or peripheral vascular disease diagnosis - Women who are postmenopausal. - Women who use a reliable contraceptive method; a reliable contraceptive method will be defined as personal history of tubal ligation, ongoing use of intra-uterine device, or ongoing use of oral contraceptive pills. Exclusion Criteria: - Presence of any CAD or stroke, transient ischemic attacks, peripheral arterial disease - Persons taking aspirin, NSAIDS, or any anti-coagulants who are medically unable to stop them for a two week pre-trial - A history of allergy to aspirin or clopidogrel - Weight < 60kg - Age < 45 and > 75 years of age - A history of recent or any active bleeding - Serious or current co-morbidity (AIDS, cancer) - Pregnant women as determined by urine dipstick pregnancy test - Any aneurysms on cranial magnetic resonance imaging/magnetic resonance angiography (obtained recently in the GeneSTAR participants) - Blood pressure above >=159/95mmHg - History of a gastric or duodenal ulcer, or significant gastrointestinal disease, like regional enteritis - Mental incompetence to make a decision to participate (developmentally disabled, and persons with diagnosed psychiatric disorders—documented in primary care records). |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University School of Medicine | Baltimore | Maryland |
Lead Sponsor | Collaborator |
---|---|
Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in platelet transcriptome | comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy | 4 weeks | No |
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