Dutch Medical Center starts a clinical trial of Dual Therapy in ACS Patients With Indication for NOAC Undergoing PCI

Photo by Vishwas Katti

Zuyderland Medical Center (Zuyderland Medisch Centrum) is enrolling patients into the clinical trial investigating Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI (RE-DUAL PCI).

The researchers think that dual therapy with Dabigatran/Ticagrelor will be non-inferior in reducing the risk of bleeding compared to Dual therapy with Dabigatran/Clopidogrel (RE-DUAL PCI trial based) in patients with an indication for NOAC undergoing PCI in the setting of ACS.

The REDUAL PCI Registry will we be an 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.

The trial is designed to enroll male and female 18 to 99 years and is being conducted in the Zuyderland MC, Heerlen, Limburg, Netherlands.

The study start date is December 23, 2020.

The population that are excluded from participation:

• Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study.
• Heart valve prosthesis (mechanical or biological).
• Cardiogenic shock
• Allergy to for Dabigatran, Ticagrelor or Clopidogrel
• Pregnancy
• Significant thrombocytopenia (platelet count < 50x10 9/L)

The detailed list can be viewed at the link below.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04688723