NCT00171769CompletedPhase 3
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
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 200
- Locations
- 3
- Primary Endpoint
- Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Study Overview
Brief Summary
This trial is designed to provide data about feasibility and safety of short-term treatment with the low-molecular-weight heparin certoparin in patients with persistent nonvalvular atrial fibrillation
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •persistent AF (electrical cardioversion is planned)
- •written informed consent
Exclusion Criteria
- •acute clinical signs of venous thromboembolism
- •current oral anticoagulation
- •indication for medical cardioversion
Outcomes
Primary Outcomes
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (3)
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