Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02164864
Status:
COMPLETED
Last Update Posted:
2018-07-31
First Post:
2014-06-13
Brief Title:
Evaluation of Dual Therapy With Dabigatran vs Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting REDUAL-PCI
Sponsor:
Boehringer Ingelheim
Organization:
Boehringer Ingelheim
Study Overview
Official Title:
A Prospective Randomised Open Label Blinded Endpoint PROBE Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate 110mg and 150mg bid Plus Clopidogrel or Ticagrelor vs Triple Therapy Strategy With Warfarin INR 20 - 30 Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation NVAF That Have Undergone a Percutaneous Coronary Intervention PCI With Stenting
Status:
COMPLETED
Status Verified Date:
2018-07
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:
The main objective of this study is to compare a Dual Antithrombotic Therapy DAT regimen of 110mg dabigatran etexilate bid plus clopidogrel or ticagrelor 110mg dabigatran etexilate DE DAT and 150mg dabigatran etexilate bid plus clopidogrel or ticagrelor 150mg DE-DAT with a Triple Antithrombotic Therapy TAT combination of warfarin plus clopidogrel or ticagrelor plus Aspirin ASA 100mg once daily warfarin-TAT in patients with Atrial Fibrillation that undergo a PCI with stenting elective or due to an Acute Coronary Syndrome
The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety Safety will be determined by comparing the rates of bleeding events assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events
The study aims to show non-inferiority of each dose of DE-DAT when compared to Warfarin-TAT in terms of safety Safety will be determined by comparing the rates of bleeding events assessed using the modified International Society of Thrombosis and Haemostasis classification of Major Bleeding and Clinically Relevant Non Major Bleeding Events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-003201-26 | EUDRACT_NUMBER | None | None |