Pharmacogenomics of Antiplatelet Response - II (PARes-II)

• Status: Completed
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: All

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 coronary artery disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Aspirin

Criteria

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).