Pharmacogenomics of Antiplatelet Response (PARes-III)

• ClinicalTrials.gov Identifier: NCT02234427
• Recruitment Status: Completed
• First Posted: September 9, 2014
• Results First Posted: January 9, 2017
• Last Update Posted: January 9, 2017
• Sponsor: Johns Hopkins University
• Information provided by (Responsible Party): Rehan Qayyum, Johns Hopkins University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Atherosclerosis	Drug: Aspirin	Phase 4

Detailed Description:

In this clinical trials we will select individuals from GeneSTAR cohort based o their platelet function. Equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. We will have baseline platelet functions performed and baseline platelet gene expression examined. Participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Pharmacogenomics of Antiplatelet Response
• Study Start Date: June 2014
• Actual Primary Completion Date: April 2015
• Actual Study Completion Date: May 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: Aspirin	Drug: Aspirin; 2-week aspirin therapy (81mg/day)

Outcome Measures

Primary Outcome Measures :

1. Differential Gene Expression [ Time Frame: 2-weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 45 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 45-75 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

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins School of Medicine

Baltimore, Maryland, United States, 21287

Sponsors and Collaborators

Johns Hopkins University

Investigators

• Principal Investigator: Rehan Qayyum, MD; Johns Hopkins School of Medicine

More Information

Additional Information:

GeneSTAR Research Program 

• Responsible Party: Rehan Qayyum, Assistant Professor, Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT02234427
• Other Study ID Numbers: PARes-III
• First Posted: September 9, 2014
• Results First Posted: January 9, 2017
• Last Update Posted: January 9, 2017
• Last Verified: November 2016

Keywords provided by Rehan Qayyum, Johns Hopkins University:

aspirin, atherosclerosis

Additional relevant MeSH terms:

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics