drugset / Trial / NCT04484259

Ticagrelor With and Without Aspirin in Patients With Diabetes Mellitus

NCT04484259 ↗

Phase 4 Completed 105 enrolled University of Florida AstraZeneca · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

Recent studies have shown that withdrawing aspirin and maintaining P2Y12 inhibitor monotherapy for up to 12 months post-PCI, after a brief period of DAPT, reduces bleeding without increasing ischemic harm. Such effects have shown to of particular benefit in patients with diabetes mellitus (DM). However, if an aspirin-free approach can be considered after this time frame is a matter of debate. The aim of this study is to assess the PD effects of ticagrelor 60 mg with and without aspirin therapy in CAD patients and to compare this with a standard DAPT regimen of aspirin plus clopidogrel.

Timeline

Start
2021-03-31
Primary completion
2024-01-29
Completion
2024-06-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 81 mg —
Comparator Clopidogrel Small molecule 75 mg —
Subject Ticagrelor Small molecule 60 mg —