drugset / Trial / NCT02201771

Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery

NCT02201771 ↗

Phase 4 Completed 500 enrolled Ruijin Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

The study population will include all patients undergoing elective CABG. Consent and randomization will occur before surgery. Total 500 patients undergoing elective CABG will be randomly assigned into three groups with 1:1:1 ratio(167 patients per group) in this open-label study. All the enrolled patients will stop oral antiplatelet drugs according to local protocol before the surgery. Within the first 24 hours after surgery, study medication should be restarted and continued for 12 months. Arm A will restart oral antiplatelet drugs by giving aspirin 100mg qd, Arm B will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid plus aspirin 100mg qd and Arm C will also restart oral antiplatelet drugs by giving ticagrelor 90mg bid. Treatment will continue for 12 months, at which time patients will undergo a multislice computed tomography angiography to assess vein graft patency. This study is designed to show the superiority of ticagrelor and ticagrelor plus aspirin as compared with aspirin monotherapy respectively for the 1-year primary efficacy end point of vein graft patency.

Timeline

Start
2014-07
Primary completion
2017-01
Completion
2017-01

Outcome

Met primary endpoint

paper The difference between ticagrelor + aspirin vs aspirin alone was statistically significant (12.2% [95% CI, 5.2% to 19.2%]; P < .001) PMID 29710164 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 100 mg Oral
Subject Ticagrelor Small molecule 90 mg Oral

Indications

No indication recorded.