Ignite Creation Date:
2024-05-06 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04688723
Status:
UNKNOWN
Last Update Posted:
2021-04-30
First Post:
2020-12-23
Brief Title:
Dual Therapy With DabigatranTicagrelor Versus Dual Therapy With DabigatranClopidogrel in ACS Patients With Indication for NOAC Undergoing PCI
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
RE-DUAL PCI Real Life Registry Dual Therapy With DabigatranTicagrelor Versus Dual Therapy With DabigatranClopidogrel in ACS Patients With Indication for NOAC Undergoing PCI
Status:
UNKNOWN
Status Verified Date:
2020-12
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:
RE-DUAL PCI
Brief Summary:
A real world registry to compare dual therapy with DabigatranTicagrelor to dual therapie with DabigatranClopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS Hypothesis Dual therapy with DabigatranTicagrelor will be non-inferior in reducing the risk of bleeding compared to Dual therapy with DabigatranClopidogrel RE-DUAL PCI trial based in patients with an indication for NOAC undergoing PCI in the setting of ACS Thromboembolic events stent thrombosis and death will be evaluated for estimation of events between both groups Data will be pooled for this secondary endpoint with data from the upcoming WOEST-3 trial to compare both treatments
Detailed Description:
The REDUAL PCI Registry will we be an open-label multicenter registry based randomised controlled trial RBRCT within the ZON-HR collaboration in 4 of the 6 centers in the Netherlands Maastricht Universitair Medisch Centrum Maastricht Zuyderland Heerlen and Sittard Vie Curi Venlo and Radboud Medisch Centrum Nijmegen Isala Zwolle and Canisius Wilhelmina ziekenhuis Nijmegen will not be part of this study This study is Investigator initiated with an unrestricted grant from Boehringer Ingelheim subsidising party This study is also to be noted as a Post Authorisation Safety Study PASS Patients 1000 patients with an indication for NOAC who underwent successful PCI with Drug Eluting Stent DES in the setting of ACS will be included and randomised at each of the 4 centers of the ZON-HR After randomisation patients will be treated with Dual therapy with DabigatranClopidogrel or with Dabigatran Ticagrelor A total of 1000 patients in 4 centers will be included 250 patients in each center In each center inclusion and randomisation will be executed within 48 hours after PCI Inclusions are expected to be done within 1 year After inclusion of the interventional Dual therapy with DabigatranTicagrelor and control group Dual therapy with DabigatranClopidogrel follow-up of 1 year is planned
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