Ignite Creation Date:
2024-05-06 @ 10:21 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03234114
Status:
RECRUITING
Last Update Posted:
2023-04-24
First Post:
2017-07-25
Brief Title:
Optimal Antithrombotic Therapy for ACS Patients Concomitant With AF and Implanted With New-generation DES OPTIMA-3 4
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
The First Affiliated Hospital with Nanjing Medical University
Study Overview
Official Title:
Optimal Antithrombotic Therapy for Acute Coronary Syndrome Patients Concomitant With Atrial Fibrillation and Implanted With New-generation Drug-eluting Stent OPTImal Management of Antithrombotic Agents OPTIMA-3 4
Status:
RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 20-30 clopidogrel 75 mg od and aspirin 100 mg od for 1 month or 6 months in a 11 ratio then quit aspirin till 12 months after percutaneous coronary intervention PCI The primary endpoint of the OPTIMA-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 11 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 OPTIMA-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
In the OPTIMA-3 sub-study 2274 subjects who choose warfarin as anticoagulant will randomly receive triple antithrombotic therapy warfarin with targeted INR 20-30 clopidogrel 75 mg od and aspirin 100 mg od for 1 month or 6 months in a 11 ratio then quit aspirin till 12 months after percutaneous coronary intervention PCI The primary endpoint of the OPTIMA-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 11 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 OPTIMA-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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None