Pharmacogenomics of Antiplatelet Response - II (PARes-II)

Atherothrombosis Clinical Trial

— PARes-II  

Official title:

Pharmacogenomics of Antiplatelet Response - II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01894555
• Other study ID #: K23HL105897-PARes-II
• 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

• Atherothrombosis

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

External Links

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