Clopidogrel Pharmacogenomics Project

NCT01097343 | Completed Phase 2 Results

• 1 other identifier: 09-2104
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Loss-of-function mutation of the gene encoding the CYP450 2C19 enzyme has emerged as a likely determinant of resistance to clopidogrel therapy. The primary hypothesis of the proposed research is that among patients with confirmed loss-of-function alleles of the CYP2C19 gene, increasing the maintenance clopidogrel dose from 75 to 150 mg will result in significant reduction in the rate of measured clopidogrel resistance defined by multiple measures of platelet function

Conditions

Disease Susceptibility

Keywords

Clopidogrel pharmacogenomics study; Performing genetic study looking at clopidogrel resistance

Outcome Measures

Primary Outcomes (1)

• Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230

  P2Y12 Reaction Units are measured using the VerifyNow P2Y12 assay. Percent of patients with clopidogrel resistance defined by PRU value will be compared among low and high dose clopidogrel groups after 30 days of therapy.

  Approximately 90 days

Study Arms (2)

75 mg clopidogrel

ACTIVE COMPARATOR

Drug: clopidogrel 75 mg

150 mg clopidogrel

ACTIVE COMPARATOR

Drug: Clopidogrel 150 mg

Interventions

clopidogrel 75 mg DRUG

75 mg once daily

Also known as: Plavix

75 mg clopidogrel

Clopidogrel 150 mg DRUG

clopidogrel 150 mg

Also known as: Plavix

150 mg clopidogrel

Eligibility Criteria

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

You may qualify if:

• No evidence of acute coronary syndrome within 30 days of enrollment, defined by elevation of Troponin I above the upper limit of normal
• Coronary atherosclerosis documented on previous coronary angiogram
• No known contraindications to combination therapy with aspirin and clopidogrel
• Prognosis for survival greater than one year based on physician's assessment
• Able to attend all scheduled visits.
• Access to phone
• Subject is a female with a negative urine or serum pregnancy test or post-menopausal for at least 1 year prior to randomization. Females of childbearing potential must be practicing adequate birth control to be eligible. It is the Investigator's responsibility for determining whether the Subject has adequate birth control for study participation

You may not qualify if:

• Recent hospitalization or physician visit for bleeding disorder(\<90 days) or history of chronic blood loss
• Recent blood transfusion (\<90 days)
• Any contraindication to aspirin or clopidogrel therapy
• Acute Febrile illness at the time of enrollment
• Subject is pregnant or lactating or planning to become pregnant

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Disease Susceptibility

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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

Results Point of Contact

• Title: Dr. Joseph S. Rossi
• Organization: St. Vincent Medical Group

jrossi@thecaregroup.com

765 482 0656

Study Officials

• Joseph Rossi, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: April 1, 2010
• Study Start: March 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: December 12, 2017
• Results First Posted: March 26, 2014

Record last verified: 2014-02

Locations

US (1)