drugset / Trial / NCT02054663

Transition From Ticagrelor to Clopidogrel Following Acute Coronary Syndrome: To Bolus or Not?

NCT02054663 ↗

Phase 4 Completed 60 enrolled Ottawa Heart Institute Research Corporation
RandomizedParallel-groupOpen-labelTreatment

Summary

After a heart attack patients are routinely started on drugs to inhibit platelets. Ticagrelor is a powerful anti-platelet drug with clinical benefits. However it must be discontinued in some, because of increased risk of bleeding or intolerance. These patients need to be transitioned to another agent, such as Clopidogrel. At present, there is no clinical consensus on the optimal strategy for this switch. Some clinicians elect to give a bolus dose of clopidogrel with 600mg, while others start directly with a 75mg daily dose, with no evidence regarding the benefits or potential complications associated with each strategy. The present proposal will evaluate the pharmacodynamics of 2 strategies with specialized platelet function testing. We hypothesize that a bolus dose of clopidogrel during the switch will confer better ischemic protection without increasing bleeding risk for patients undergoing a switch in therapy.

Timeline

Start
2013-12
Primary completion
2015-02
Completion
2015-02

Outcome

Missed primary endpoint

paper At 72 h, no difference in PRU was observed (165.8 ± 71.0 vs 184.1 ± 67.7, bolus vs no bolus, respectively, p=0.19). PMID 27761582 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Clopidogrel Small molecule 75 mg —