Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI

Summary

Participation Requirements

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 Radbo...

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 Dabigatran/Clopidogrel 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 Dabigatran/Ticagrelor) and control group (Dual therapy with Dabigatran/Clopidogrel), follow-up of 1 year is planned.

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