Status:
COMPLETED
Pharmacogenomics of Antiplatelet Response - II (PARes-II)
Lead Sponsor:
Johns Hopkins University
Conditions:
Atherothrombosis
Eligibility:
All Genders
45-75 years
Phase:
PHASE4
Brief Summary
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 coronar...
Detailed Description
Platelet aggregation can initiate thrombosis on ulcerated arterial plaques resulting in acute coronary syndrome (ACS). There is large variation in platelet aggregation between individuals. As the gene...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01894555
Start Date
January 1 2013
End Date
August 1 2014
Last Update
January 9 2017
Active Locations (1)
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1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287