Persistent Nonvalvular Atrial Fibrillation Clinical Trial
Official title:
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
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Completed |
| Enrollment | 200 |
| Est. completion date | |
| Est. primary completion date | August 2006 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Novartis Pharmaceuticals | East Hanover | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis |
United States, Germany,
Tebbe U, Oeckinghaus R, Appel KF, Heuer H, Haake H, Eggers E, Seidel K, Adams J, Harenberg J. AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients wi — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events |