Pharmacogenomics of Antiplatelet Response - II (PARes-II)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Johns Hopkins University
Sponsor:
Information provided by (Responsible Party):
Rehan Qayyum, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01894555
First received: July 3, 2013
Last updated: September 17, 2013
Last verified: July 2013

July 3, 2013
September 17, 2013
January 2013
December 2014   (final data collection date for primary outcome measure)
Changes in platelet transcriptome [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
comparison of platelet transcriptome before aspirin therapy with platelet transcriptome after aspirin therapy
Same as current
Complete list of historical versions of study NCT01894555 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Atherothrombosis
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2014
December 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).
Both
45 Years to 75 Years
No
Contact: Taryn F Moy, MS 410-614-2440 tmoy1@jhmi.edu
Contact: Rehan Qayyum, MD 443-287-3631 rqayyum@jhmi.edu
United States
 
NCT01894555
K23HL105897-PARes-II
Yes
Rehan Qayyum, Johns Hopkins University
Johns Hopkins University
Not Provided
Principal Investigator: Rehan Qayyum, MD Johns Hopkins School of Medicine
Johns Hopkins University
July 2013

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