Status:
UNKNOWN
Dual Therapy With Dabigatran/Ticagrelor Versus Dual Therapy With Dabigatran/Clopidogrel in ACS Patients With Indication for NOAC Undergoing PCI
Lead Sponsor:
Zuyderland Medisch Centrum
Collaborating Sponsors:
Boehringer Ingelheim
Conditions:
Coronary Artery Disease
Myocardial Ischemia
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
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. Hypo...
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 Uni...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT04688723
Start Date
December 23 2020
End Date
July 1 2023
Last Update
April 30 2021
Active Locations (1)
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1
Zuyderland MC
Heerlen, Limburg, Netherlands, 6419PC