Back to resultsAtrial Fibrillation Feasibility Certoparin Trial - AFFECT
Primary Purpose
Persistent Nonvalvular Atrial Fibrillation
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Certoparin
Sponsored by
About this trial
This is an interventional treatment trial for Persistent Nonvalvular Atrial Fibrillation
Eligibility Criteria
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
Sites / Locations
- Novartis Pharmaceuticals
Outcomes
Primary Outcome Measures
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00171769
Brief Title
Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
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 Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Persistent Nonvalvular Atrial Fibrillation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Certoparin
Primary Outcome Measure Information:
Title
Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
novartis pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Pharmaceuticals
City
East Hanover
State/Province
New Jersey
ZIP/Postal Code
07936
Country
United States
City
Investigative Centers
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
18322636
Citation
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 with persistent non-valvular atrial fibrillation. Clin Res Cardiol. 2008 Jun;97(6):389-96. doi: 10.1007/s00392-008-0644-y. Epub 2008 Mar 5.
Results Reference
result
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Atrial Fibrillation Feasibility Certoparin Trial - AFFECT
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