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Pharmacogenomics of Antiplatelet Response - II (PARes-II) (PARes-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01894555
Recruitment Status : Completed
First Posted : July 10, 2013
Results First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Information provided by (Responsible Party):
Rehan Qayyum, Johns Hopkins University

Brief 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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Pharmacogenomics of Antiplatelet Response - II
Study Start Date : January 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Aspirin
Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Drug: Aspirin
81 mg daily for 4 weeks

Primary Outcome Measures :
  1. Changes in Platelet Transcriptome [ Time Frame: 4 weeks ]

    Comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after 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

Information from the National Library of Medicine

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

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01894555

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United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
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Principal Investigator: Rehan Qayyum, MD Johns Hopkins School of Medicine

Additional Information:
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Responsible Party: Rehan Qayyum, Assistant Professor of Medicine, Johns Hopkins University Identifier: NCT01894555    
Other Study ID Numbers: K23HL105897-PARes-II
K23HL105897 ( U.S. NIH Grant/Contract )
First Posted: July 10, 2013    Key Record Dates
Results First Posted: January 9, 2017
Last Update Posted: January 9, 2017
Last Verified: November 2016
Keywords provided by Rehan Qayyum, Johns Hopkins University:
Platelet Transcriptome
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Additional relevant MeSH terms:
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Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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