drugset / Trial / NCT02303717
Xience Versus Synergy in Left Main PCI
Unknown
818 enrolled
NHS National Waiting Times Centre Board
Boston Scientific Corporation · collabCardialysis B.V. · collabDiagram B.V. · collabVenn Life Sciences · collab
RandomizedParallel-groupSingle-blindTreatment
Summary
A prospective, randomized, multicenter study in patients with an indication for coronary artery revascularisation who have been accepted for percutaneous coronary intervention (PCI) of the left main coronary artery. Patients will undergo standard PCI of the left main coronary artery and will be randomized in a 1:1 fashion to the Synergy stent or to the XIENCE stent. Dual antiplatelet therapy (DAPT) will be stopped at t=4 months in the Synergy arm whereas in the control arm DAPT will be continued for 12 months. A subgroup of 100 patients will have control angiography with Optical Coherence Tomography (OCT) at t=3 months after treatment.
Timeline
- Start
- 2014-12
- Primary completion
- 2017-12
- Completion
- 2020-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Aspirin | Small molecule | 75 mg | Oral |
| Background | Aspirin | Small molecule | 100 mg | Oral |
| Background | Clopidogrel | Small molecule | 75 mg | Oral |
| Background | Prasugrel | Small molecule | 5 mg | Oral |
| Background | Prasugrel | Small molecule | 10 mg | Oral |
| Background | Ticagrelor | Small molecule | 90 mg | Oral |