An open-label, multi-center trial to evaluate the feasibility and safety of short-term treatment with subcutaneously injected certoparin (8000 U anti-Xa twice daily) in patients with persistent nonvalvular atrial fibrillation - AFFECT
- Conditions
- MedDRA version: M15Level: LLTClassification code 10003658Atrial fibrillation
- Registration Number
- EUCTR2004-002888-24-DE
- Lead Sponsor
- ovartis Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
•women or men =18 years
•persistent AF (electrical cardioversion is planned)
•written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
•unsuccessful cardioversion in the past
•UFH or LMWH for more than 48 hours before start of study drug
•current oral anticoagulation
•indication for medical cardioversion
•acute clinical signs of venous thromboembolism
•platelet count <100000/µL
•body weight <60 kg
•known hypersensitivity to certoparin or heparin
•recent (within the last 3 months) or active bleeding
•acute (or suspicion of) stroke, intracranial bleeding or cerebral aneurysm
•severe uncontrolled hypertension
•known severe hepatic or renal insufficiency or serum creatinine >2 mg/dL
•known pregnancy or breastfeeding or women of childbearing potential without reliable contraception
•participation in another investigative drug study within the last 30 days
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