drugset / Trial / NCT05952206
Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy
RandomizedFactorialOpen-labelTreatment
Summary
Factorial 2x2, all-comer, multicentre, randomized controlled trial (ratio 1:1:1:1). First, the study will compare (first randomization) the non-inferiority in target lesion failure of angiolite stent versus Xience stent family. Immediately after the first randomization, the study compares (second randomization) the superiority in bleeding Bleeding Academic Research Consortium (BARC) 2, 3, or 5 of abbreviated DAPT versus standard of care. Both primary endpoints will be evaluated at 12 months of follow-up. The study will be open-label for the stent type and the antiplatelet regimen.
Timeline
- Start
- 2023-10-13
- Primary completion
- 2027-01-13
- Completion
- 2030-01-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Aspirin | Small molecule | — | — |
| Subject | Clopidogrel | Small molecule | — | Oral |
| Subject | Prasugrel | Small molecule | — | Oral |
| Subject | Ticagrelor | Small molecule | — | Oral |