drugset / Trial / NCT03797651

Ticagrelor Monotherapy in PAtients Treated With New-generation Drug-eluting Stents for Acute Coronary Syndrome; T-PASS Trial

NCT03797651

Unknown 2850 enrolled Yonsei University
RandomizedParallel-groupOpen-labelTreatment

Summary

We hypothesized that ticagrelor monotherapy might be enough to prevent thromboembolic events without aspirin after PCI in patients with acute coronary syndrome(ACS). Moreover, ticagrelor monotherapy will reduce bleeding risk compared to DAPT with aspirin plus ticagrelor. We will also evaluate 1-year safety and efficacy of Orsiro stent for patient with acute coronary syndrome. After confirmation of enrollment, patients will be randomized to continue standard treatment (aspirin plus ticagrelor) for 1 year or to stop aspirin after discharge or less than 1 month after PCI (ticagrelor monotherapy). Randomization will be stratified according to 1) the presence of diabetes and 2) ST elevation myocardial infarction (MI). Baseline clinical and angiographic characteristics, laboratory findings will be assessed at the time of randomization. All patients will provide informed consent on their own initiative.

Timeline

Start
2019-04-24
Primary completion
2025-04-04
Completion
2025-04-04

Drugs

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