WOEST-3
- Conditions
- Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]Atrial fibrillationAcute coronary syndromeChronic coronary syndrome
- Registration Number
- CTIS2022-502140-13-00
- Lead Sponsor
- St Antonius Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 2550
=18 years of age, Undergoing successful PCI, History of or newly diagnosed (<72 hours after PCI/ACS) atrial fibrillation or flutter with a long-term (= 1 year) indication for OAC
Contra indication to edoxaban, aspirin or all P2Y12 inhibitors (e.g. kidney failure (eGFR <15) or allergy), Life expectancy <1 year, Other oral anticoagulation than NOAC or acenocoumarol at randomization (e.g. fenprocoumon), Active malignancy with metastases or non-curative treatment (e.g. palliative chemotherapy), Known coagulopathy, Active bleeding on randomization, History of intraocular, spinal, retroperitoneal, or traumatic intra-articular bleeding, unless the causative factor has been permanently resolved, Recent (<1 month) gastrointestinal haemorrhage, unless the causative factor has been permanently resolved., Severe anaemia requiring blood transfusion or thrombocytopenia <50 × 10^9/L, Pregnancy or breast-feeding women, BMI >40 or bariatric surgery, Poor LV function (LVEF <30%) with proven slow-flow, <12 months after any stroke, CHA2DS2VASc score =7, Current indication for OAC besides atrial fibrillation/flutter (e.g. venous thromboembolism, mechanical heart valve prosthesis, intracardiac thrombus or apical aneurysm requiring OAC), History of intracranial haemorrhage, Moderate to severe mitral valve stenosis (AVA =1.5 cm2), Active liver disease (ALT, ASP, AP >3x ULN or active hepatitis A, B or C)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: 1. To assess bleeding risk (i.e. safety) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.<br>2. To assess ischemic risk (i.e. efficacy) with 30-day DAPT compared to standard therapy at 6 weeks after successful PCI in patients with AF.;Secondary Objective: To assess bleeding risk (i.e. safety) and ischemic risk (i.e. efficacy) with 30-day DAPT compared to standard therapy at 6 months after successful PCI in patients with AF., To perform an exploratory analysis of the individual components of the main secondary endpoint and quality of life.;Primary end point(s): The safety endpoint is major or clinically relevant non-major bleeding as defined by the ISTH at 6 weeks after PCI., The co-primary efficacy endpoint is a composite of all-cause death, myocardial infarction, stroke, systemic embolism, or stent thrombosis at 6 weeks after PCI.
- Secondary Outcome Measures
Name Time Method Secondary end point(s):Key secondary endpoints include the primary safety and efficacy outcomes at 6 months after successful PCI.;Secondary end point(s):Exploratory analysis of the individual components of the main secondary endpoint;Secondary end point(s):Net clinical benefit comprising of major bleeding, myocardial infarction, stroke, systemic embolism, all cause death, and stent thrombosis;Secondary end point(s):Quality of life