Phase 2 Completed N=333 Randomized Quadruple-blind Treatment

Escalating Clopidogrel by Involving a Genetic Strategy - Thrombolysis In Myocardial Infarction 56

Myocardial Infarction · Percutaneous Coronary Intervention

Source: ClinicalTrials.gov NCT01235351 ↗

Enrolled (actual)

333

Serious AEs

5.8%

Results posted

Nov 2019

Primary outcomePrimary: Comparisons of Vasodilator-stimulated Phosphoprotein (VASP) Phosphorylation Platelet Reactivity Index (PRI) — 71.0; 57.5; 62.4; 46.9 % of PRI

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.

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	—

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.

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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. Informational only — not medical advice.