Phase 4 N=33 Basic Science

Pharmacogenomics of Antiplatelet Response - II (PARes-II)

Atherothrombosis

Bottom Line

View on ClinicalTrials.gov: NCT01894555 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2017

Primary outcome: Primary: Changes in Platelet Transcriptome — 77.1 FPKM difference for HBG1 Gene

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Aspirin (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Johns Hopkins University
Primary completion: Aug 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Platelet Transcriptome	77.1	—

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.

Eligibility 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 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).

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01894555). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.