Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03536611
Status:
UNKNOWN
Last Update Posted:
2019-01-04
First Post:
2018-04-25
Brief Title:
Dabigatran Versus Warfarin With NVAF Who Undergo PCI
Sponsor:
Shenyang Northern Hospital
Organization:
Shenyang Northern Hospital
Study Overview
Official Title:
A Randomized Study Comparing Dabigatran Etexilate Versus Warfarin in Chinese Patients With Nonvalvular Atrial Fibrillation Who Undergo Percutaneous Coronary Intervention With Stenting DES
Status:
UNKNOWN
Status Verified Date:
2019-01
Last Known Status:
RECRUITING
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:
COACH-AF-PCI
Brief Summary:
This study is to compare the efficacy and safety of dabigatran ethidium bid clopidogrel ASA 100 mg qd 1 month and warfarin clopidogrel ASA 100 mg qd1 month in Chinese NVAF patients undergoing PCI with stenting elective or due to ACS
Detailed Description:
This is an open-label multi-center randomized controlled prospective studyThe object of this study is to compare the safety and efficacy of dabigatran etexilate combined with dual anti-platelet therapy versus warfarin combined with dual anti-platelet therapy in Chinese patients with nonvalvular atrial fibrillation who undergo percutaneous coronary intervention
The subjects are randomized into study group and control group using central randomization for open-label dosing1 Study group dabigatran etexilate 110 mg bid aspirin 100 mg qd clopidogrel 75 mg qd Aspirin is withdrawn 1 month later2 Control group warfarin according to clinical routine monitoring of INR maintain the therapeutic rang at 20-30 aspirin 100 mg qd clopidogrel 75 mg qd Aspirin is withdrawn 1 month laterAll patients should receive the study medication for 6 month
Primary endpointTime to the first occurrence of BARC-defined grade 2-5 clinically relevant bleeding
Key secondary endpointTime to the first occurrence of net clinical adverse events Net clinical adverse event is composed of major cardiovascular and cerebrovascular adverse events all death recurrent myocardial infarction ischemia-induced revascularization of the target vessel or strokesystemic embolism or BARC-defined grade 2-5 clinically relevant bleeding
Secondary endpoints1 Major cardiovascular and cerebrovascular adverse events 2 Major bleeding or clinically relevant non-major bleeding ISTH definition 3 Major bleeding ISTH definition 4 Any bleeding event BARC-defined grade 1-5 5 Clinically relevant bleeding BARC-defined grade 2-5 6 Bleeding BARC-defined grade 3-5
The subjects are randomized into study group and control group using central randomization for open-label dosing1 Study group dabigatran etexilate 110 mg bid aspirin 100 mg qd clopidogrel 75 mg qd Aspirin is withdrawn 1 month later2 Control group warfarin according to clinical routine monitoring of INR maintain the therapeutic rang at 20-30 aspirin 100 mg qd clopidogrel 75 mg qd Aspirin is withdrawn 1 month laterAll patients should receive the study medication for 6 month
Primary endpointTime to the first occurrence of BARC-defined grade 2-5 clinically relevant bleeding
Key secondary endpointTime to the first occurrence of net clinical adverse events Net clinical adverse event is composed of major cardiovascular and cerebrovascular adverse events all death recurrent myocardial infarction ischemia-induced revascularization of the target vessel or strokesystemic embolism or BARC-defined grade 2-5 clinically relevant bleeding
Secondary endpoints1 Major cardiovascular and cerebrovascular adverse events 2 Major bleeding or clinically relevant non-major bleeding ISTH definition 3 Major bleeding ISTH definition 4 Any bleeding event BARC-defined grade 1-5 5 Clinically relevant bleeding BARC-defined grade 2-5 6 Bleeding BARC-defined grade 3-5
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?:
False
Is an FDA AA801 Violation?:
None