drugset / Trial / NCT05681702
Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI
RandomizedParallel-groupOpen-labelTreatment
Summary
Two strategies have both proven to be effective in reducing bleeding complications while preserving efficacy compared with maintaining long-term DAPT with aspirin and a potent P2Y12 inhibitor: a) DAPT de-escalation (i.e., switching from prasugrel or ticagrelor to clopidogrel while maintaining aspirin) and b) potent P2Y12 inhibitor monotherapy (i.e., maintaining prasugrel or ticagrelor and dropping aspirin). These strategies have been tested in a number of trials and have led to changes in practice guidelines to consider either one of these strategies as bleeding reduction approaches among ACS patients undergoing PCI. However, comparative assessments between DAPT de-escalation and potent P2Y12 inhibitor monotherapy are lacking.
Timeline
- Start
- 2023-02-15
- Primary completion
- 2026-12-31
- Completion
- 2027-03-31
Publications
- Background Capodanno D, Baber U, Bhatt DL, Collet JP, Dangas G, Franchi F, Gibson CM, Gwon HC, Kastrati A, Kimura T, Lemos PA, Lopes RD, Mehran R, O'Donoghue ML, Rao SV, Rollini F, Serruys PW, Steg PG, Storey RF, Valgimigli M, Vranckx P, Watanabe H, Windecker S, Angiolillo DJ. P2Y12 inhibitor monotherapy in patients undergoing percutaneous coronary intervention. Nat Rev Cardiol. 2022 Dec;19(12):829-844. doi: 10.1038/s41569-022-00725-6. Epub 2022 Jun 13.
- Background Capodanno D, Bhatt DL, Gibson CM, James S, Kimura T, Mehran R, Rao SV, Steg PG, Urban P, Valgimigli M, Windecker S, Angiolillo DJ. Bleeding avoidance strategies in percutaneous coronary intervention. Nat Rev Cardiol. 2022 Feb;19(2):117-132. doi: 10.1038/s41569-021-00598-1. Epub 2021 Aug 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aspirin | Small molecule | 81 mg | — |
| Comparator | Clopidogrel | Small molecule | 75 mg | Oral |
| Subject | Prasugrel | Small molecule | 10 mg | Oral |
| Subject | Ticagrelor | Small molecule | 90 mg | Oral |