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

NCT ID: NCT04688723

Last Updated: 2021-04-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-23
• Study Completion Date: 2023-07-01

Brief Summary

A real world registry to compare dual therapy with Dabigatran/Ticagrelor to dual therapie with Dabigatran/Clopidogrel in patients with an indication for NOAC undergoing PCI in the setting of ACS. Hypothesis: 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. 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 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.

Conditions

Coronary Artery Disease; Myocardial Ischemia; Myocardial Infarction; Atrial Fibrillation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dabigatran/Clopidogrel

Patiënt receive standard care, with dabigatran + clopidogrel 75mg once daily up to 12 months.

Group Type: ACTIVE_COMPARATOR

Dabigatran + clopidogrel

Intervention Type: DRUG

Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.

Dabigatran/Ticagrelor

Patiënt receive standard care, with dabigatran + ticagrelor 90mg twice daily up to 12 months.

Group Type: EXPERIMENTAL

Dabigatran + Ticagrelor

Intervention Type: DRUG

Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.

Interventions

Dabigatran + Ticagrelor

Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.

Intervention Type: DRUG

Dabigatran + clopidogrel

Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years
• Patients having an indication for a NOAC or will start with oral anticoagulation (NOAC). Permanent, persistent or paroxysmal atrial fibrillation are eligible.
• PCI and successful stenting with DES for ACS (unstable angina pectoris, NSTEMI, STEMI)
• Written informed consent.

Exclusion Criteria

• Patients unable or unwilling to comply with the protocol or with life expectancy shorter than the duration of the study
• Glomerular filtration rate < 30 ml/min
• Heart valve prosthesis (mechanical or biological)
• Cardiogenic shock
• Contra-indication for Dabigatran, Ticagrelor or Clopidogrel

• Liver dysfunction (ALAT, ASAT, Alkaline phosphatase > 3x upper limit of normal) or liver disease (like hepatitis A, B, C)
• Lesion or condition with a significant risk of serious bleeding, such as; current or recent gastrointestinal ulceration; malignant neoplasms with more bleeding risk; recent brain / spinal cord injury; recent surgery on the brain, spinal cord or eyes; recent or history of intracranial haemorrhage; oesophageal varices; arteriovenous malformations; vascular aneurysms; o severe intraspinal or intracerebral vascular abnormalities.
• comedication with cyclosporine, itraconazole, ketoconazole (systemic) and glecaprevir / pibrentasvir, dronedarone, rifampicine, carbamazepine, St. Jan's wort or phenytoin o Comedication with tacrolimus is not recommended.
• Allergy to for Dabigatran, Ticagrelor or Clopidogrel
• Pregnancy
• Significant thrombocytopenia (platelet count < 50x10 9/L)
• Major bleeding according to BARC ≥3 within the past 6 months.
• Weight < 50 kg

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: collaborator

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zuyderland MC

Heerlen, Limburg, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Facility Contacts

Patty Winkler

Role: primary

p.winkler@zuyderland.nl

+31 6 53368084

Other Identifiers

METCZ20200196

Identifier Type: -

Identifier Source: org_study_id