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

July 3, 2013
July 10, 2013
August 1, 2016
January 9, 2017
January 9, 2017
January 2013
August 2014   (Final data collection date for primary outcome measure)
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

Changes in Platelet Transcriptome [ Time Frame: 4 weeks ]
comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy
Complete list of historical versions of study NCT01894555 on Archive Site
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Pharmacogenomics of Antiplatelet Response - II (PARes-II)
Pharmacogenomics of Antiplatelet Response - II
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.
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.
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Drug: Aspirin
81 mg daily for 4 weeks
Experimental: Aspirin
Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.
Intervention: Drug: Aspirin
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
August 2014
August 2014   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
45 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
K23HL105897 ( U.S. NIH Grant/Contract )
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Rehan Qayyum, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Rehan Qayyum, MD Johns Hopkins School of Medicine
Johns Hopkins University
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP