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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01894555
Other study ID # K23HL105897-PARes-II
Secondary ID
Status Completed
Phase Phase 4
First received July 3, 2013
Last updated September 5, 2014
Start date January 2013
Est. completion date August 2014

Study information

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

Clinical Trial 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.


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 genetic message to the cell machinery is conveyed through its transcriptome, we hypothesize that much of the variability in platelet function can be explained by transcriptome changes including differences in gene or isoform expression, altered splicing events, or allele-specific expression. Moreover, aspirin modifies gene expression in several cells, but whether it also affects platelet transcriptome has not yet been studied. Our goal is to characterize the platelet transcriptome and identify genes that are up- or down-regulated after 4-week aspirin therapy. A major strength of our study is that it enrolls individuals from European Americans and African Americans and thus will have the ability to study similarities and differences between the two. The study will produce innovative comparative genomic/platelet phenotype data and will provide a potential pharmacogenomic and diagnostic template for the future discovery of novel antiplatelet regimens to prevent thrombosis-related cardiovascular disease events.


Recruitment information / eligibility

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).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Drug:
Aspirin
81 mg daily for 4 weeks

Locations

Country Name City State
United States Johns Hopkins University School of Medicine Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

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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