What is the optimal strategy of blood thinners in patients with atrial fibrillation and a heart attack or coronary stent?
Phase 1
- Conditions
- Atrial fibrillation and coronary artery diseaseTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2022-001298-30-NL
- Lead Sponsor
- St. Antonius Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria
1. =18 years of age
2. Undergoing PCI or presenting with ACS with elevated cardiac markers (CK/CK-MB, troponin)
3. History of or newly diagnosed atrial fibrillation or flutter with a long-term (= 1 year) indication for OAC
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 500
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1500
Exclusion Criteria
1. Contra indication to edoxaban
2. <3 months after any stroke
3. <3 months after venous thrombo embolism
4. Mechanical heart valve prosthesis
5. Moderate to severe mitral valve stenosis
6. Intracardiac thrombus
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method