Pharmacogenomics of Antiplatelet Response

NCT02234427 | Completed Phase 4 Results DMC

• 1 other identifier: PARes-III
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease

Conditions

Atherosclerosis

Keywords

aspirin, atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Differential Gene Expression

  Differences in platelet transcriptome before and after 2-week aspirin therapy The expression levels of genes before aspirin therapy was compared with the expression level of the genes after aspirin therapy. The expression levels were measured using the FPKM unit (Fragments Per Kilobase of transcript per Million mapped reads). The gene with the highest difference (pre vs. post) in FPKM is being reported with name in the units area and the actual difference in the number area

  2-weeks

Study Arms (1)

Aspirin

EXPERIMENTAL

Drug: Aspirin

Interventions

Aspirin DRUG

2-week aspirin therapy (81mg/day)

Aspirin

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years
• GeneSTAR participant
• No personal History of Coronary Artery Disease
• Women who are post-menopausal
• Women who are using a reliable method of contraception, such as history of tubal ligation, IUD or taking OCP

You may not qualify if:

• Taking aspirin prescribed by physician
• weight \< 60 kg
• History of recent or current bleeding
• allergy to aspirin or history of adverse events to aspirin
• serious comorbid conditions (such as AIDS, active cancer)
• high blood pressure (\>160/95)
• History of gastrointestinal ulcer/bleeding
• Mental incompetence to make decision to participate.

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Links

• GeneSTAR Research Program

MeSH Terms

Conditions

Atherosclerosis

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Results Point of Contact

• Title: Rehan Qayyum
• Organization: Johns Hopkins School of Medicine

rqayyum@jhmi.edu

410-955-7781

Study Officials

• Rehan Qayyum, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 5, 2014
• First Posted: September 9, 2014
• Study Start: June 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Locations

US (1)