Pharmacogenomics of Antiplatelet Response - I

NCT01815008 | Completed Phase 4 Results DMC

• 2 other identifiers: K23HL105897-PARes-IK23HL105897
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial is examining the role of genetic polymorphism on the effect of clopidogrel (with or without aspirin) on platelet response in persons at high-risk for myocardial infarction or stroke due to family history of early-onset coronary artery disease.

Conditions

Platelet Aggregation; Platelet Transcriptome; Coronary Artery Disease

Keywords

Platelet aggregation; Clopidogrel; Platelet transcriptome

Outcome Measures

Primary Outcomes (1)

• Difference in ADP-induced Platelet Aggregation

  ADP-induced platelet aggregation will be measured using impedance aggregometry in whole blood before and after 1-week of clopidogrel. The difference between the baseline and after clopidogrel therapy will be determined. Higher impedance represent higher platelet aggregation.

  at baseline and at 1 week

Secondary Outcomes (3)

• Difference in Arachidonic Acid-induced Platelet Aggregation

  At baseline and after 1-week

• Difference in Collagen-induced Platelet Aggregation

  At Baseline and at 1 week

• Changes in Platelet Transcriptome With Clopidogrel

  At baseline and at 1 week

Study Arms (1)

Clopidogrel

EXPERIMENTAL

Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily

Drug: Clopidogrel; Drug: Aspirin

Interventions

Clopidogrel DRUG

Clopidogrel 75 mg daily

Also known as: Plavix

Clopidogrel

Aspirin DRUG

Aspirin 81 mg daily

Clopidogrel

Eligibility Criteria

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

You may qualify if:

• Participants from the GeneSTAR cohort
• Unaffected with no overt coronary artery disease or serious vascular event (stroke or peripheral vascular disease diagnosis
• Presence of an occult coronary artery disease phenotype as defined by coronary artery calcium scores about the MESA (Multiethnic Study of Atherosclerosis) 75th percentile for age sex, and race or ≥ 1 stenoses in any of the major coronary arteries or main branches of \> 50%, or coronary plaque volumetric scores above our own 75th percentile, or any combination on cardiac computed tomographic angiography (performed recently as part of the GeneSTAR study and present for all persons being recruited)/
• Presence of occult cerebrovascular disease defined as presence of white matter hyperintensities (WMH) thought to represent ischemic small vessel cerebrovascular disease, and /or the presence of lacunes (old small strokes), or the presence of an Atherosclerosis Risk in Communities Study (ARIC) silent stroke score on a visual analogue scales of 4 or more (on a scale of 0-9).
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Links

• GeneSTAR Research Program

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

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 University

  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: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: March 18, 2013
• First Posted: March 20, 2013
• Study Start: October 1, 2012
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 9, 2017
• Results First Posted: January 9, 2017

Record last verified: 2016-11

Locations

US (1)