drugset / Trial / NCT05952206

Ischemic and Bleeding Outcomes After Angiolite Stent Implantation and an Abbreviated Dual Antiplatelet Therapy

NCT05952206

Phase 3 Active not recruiting 2312 enrolled iVascular S.L.U.
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

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule
Subject Clopidogrel Small molecule Oral
Subject Prasugrel Small molecule Oral
Subject Ticagrelor Small molecule Oral