Optimal Antithrombotic Therapy for ACS Patients Concomitant With AF and Implanted With New-generation DES (OPTIMA-3, 4)
Status:
Recruiting
Trial end date:
2023-12-31
Target enrollment:
Participant gender:
Summary
It is a multi-center randomized clinical trial (RCT) which will enroll 3746 patients with
acute coronary syndrome (ACS) concomitant non-valvular atrial fibrillation (NVAF) and
undergoing new generation drug eluting stent (DES) implantation at 70 centers nationwide in
China and contains two sub-studies.
In the OPTIMA-3 sub-study, 2274 subjects who choose warfarin as anticoagulant will randomly
receive triple antithrombotic therapy (warfarin with targeted INR 2.0-3.0, clopidogrel 75 mg
od and aspirin 100 mg od) for 1 month or 6 months in a 1:1 ratio then quit aspirin till 12
months after percutaneous coronary intervention (PCI). The primary endpoint of the OPTIMAL-3
is a composite of cardiovascular death, myocardial infarction, ischemic stroke, systemic
thromboembolism and unplanned revascularization up to 12 months; the major secondary endpoint
is the International Society of Thrombosis and Hemostasis (ISTH) major bleeding or clinically
relevant non-major bleeding (CRNMB).
In the OPTIMA-4 sub-study, 1472 subjects who prefer dabigatran will be randomly assigned in a
1:1 ratio to a dual antithrombotic therapy of dabigatran 110 mg twice daily with ticagrelor
90 mg twice daily or with clopidogrel 75 mg od for 12 months after PCI. The primary safety
endpoint of the OPTIMAL-4 is ISTH major bleeding or CRNMB at 12 months; the primary efficacy
endpoint is a composite of cardiovascular death, myocardial infarction, ischemic stroke,
systemic thromboembolism and unplanned revascularization.
Other secondary endpoints comprise death (cardiovascular, non- cardiovascular), MI (fatal or
non-fatal, Q-wave or non-Q-wave), unplanned revascularization (target or non-target vessel,
target or non-target lesion), stent thrombosis (possible, probable, definite), stroke
(hemorrhage or ischemic), all bleeding (ISTH and BARC criteria) and net adverse events.
All endpoints will be collected and compared between subgroups and sub-studies during
hospitalization and in 1 month (± 7 days), 6 months (± 7 days) and 12 months (± 7 days) for
office visits and in 2 weeks (± 7 days), 2 months (± 7 days) and 3 months (± 7 days) for
phone call visits.
Phase:
Phase 4
Details
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University