Phase 2
N=333
Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56
Myocardial Infarction · Percutaneous Coronary Intervention
Bottom Line
View on ClinicalTrials.gov: NCT01235351 ↗Enrolled (actual)
333
Serious AEs
5.8%
Results posted
Nov 2019
Primary outcome: Primary: Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI) — 71.0; 57.5; 62.4; 46.9 % of PRI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Clopidogrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The TIMI Study Group
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI) |
71.0; 57.5; 62.4; 46.9; 54.0; 50.1 | — |
Summary
To determine whether higher as compared with lower maintenance doses of clopidogrel can adequately improve the degree of platelet inhibition in carriers of a reduced-function CYP2C19 allele.
Eligibility Criteria
Inclusion Criteria (major):
- Between 18 and 75 years of age, inclusive.
- Have an indication for the use of clopidogrel defined as either spontaneous MI [hospitalized with final diagnosis of MI, excluding periprocedural or definite secondary MI (e.g., due to anemia or hypertensive emergency)] or PCI within the past 6 months.
- Clinically stable and at least 4 weeks following the MI or PCI.
Exclusion Criteria (major):
- Conditions that alter platelet function.
- Conditions that increase bleeding risk.
Data sourced from ClinicalTrials.gov (NCT01235351). 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.