drugset / Trial / NCT01755520

Study Comparing Ticagrelor With Aspirin for Prevention of Vascular Events in Patients Undergoing CABG

NCT01755520 ↗

Phase 3 Terminated 1893 enrolled German Heart Center Munich AstraZeneca · collab
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary objective of this study ist to test the hypothesis that ticagrelor is superior to Aspirin (ASA) fort he prevention of major cardio- and cerebrovascular events (MACCE) in patients undergoing artery bypass operation. The primary efficiacy MACCE-endpoint is the composite of cardiovascular death, myocardial infarction, recurent revascularisation, and stroke at twelve month after coronary artery bypass operation.

Timeline

Start
2013-04-24
Primary completion
2018-05-19
Completion
2018-05-19

Outcome

Missed primary endpoint

Stopped: “DSMB Interim Analyses”

paper [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. PMID 31145798 ↗

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 100 mg —
Subject Ticagrelor Small molecule 90 mg —