Phase 2
N=50
Clopidogrel Pharmacogenomics Project
Disease Susceptibility
Bottom Line
View on ClinicalTrials.gov: NCT01097343 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
Mar 2014
Primary outcome: Primary: Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230 — 30; 18 Number of Patients with PRU>230 — p==0.02
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- clopidogrel 75 mg (Drug); Clopidogrel 150 mg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clopidogrel Resistance, Defined by P2Y12 Reaction Units (PRU)Value >230 |
30; 18 | =0.02 sig |
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
Eligibility Criteria
Inclusion Criteria:• Currently taking clopidogrel 75 mg/day and aspirin (minimum 81 mg/day) with an indication for chronic dual antiplatelet therapy (>90 days)
- 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
Exclusion Criteria:• Recent acute coronary syndrome (<30 days)
- 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
Data sourced from ClinicalTrials.gov (NCT01097343). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.