Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00171769
Collaborator
(none)
200
2
100
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date
:
Apr 1, 2005
Actual Primary Completion Date
:
Aug 1, 2006
Outcome Measures
Primary Outcome Measures
- Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events []
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Pharmaceuticals | East Hanover | New Jersey | United States | 07936 |
| 2 | Investigative Centers | Germany |
Sponsors and Collaborators
- Novartis
Investigators
- Study Director: novartis pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00171769
Other Study ID Numbers:
- CMEX839BDE01
First Posted:
Sep 15, 2005
Last Update Posted:
Feb 23, 2017
Last Verified:
Feb 1, 2017