Phase 4
Completed N=33
Pharmacogenomics of Antiplatelet Response - II (PARes-II)
Atherothrombosis
Source: ClinicalTrials.gov NCT01894555 ↗
Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Changes in Platelet Transcriptome — 77.1 FPKM difference for HBG1 Gene
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Changes in Platelet Transcriptome |
77.1 | — |
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).
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. Informational only — not medical advice.