Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00171769
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : February 23, 2017
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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
Persistent Nonvalvular Atrial Fibrillation Drug: Certoparin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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 : April 2005
Primary Completion Date : August 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00171769

United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Investigative Centers, Germany
Sponsors and Collaborators
Study Director: novartis pharmaceuticals Novartis Pharmaceuticals

Additional Information:
Publications of Results: Identifier: NCT00171769     History of Changes
Other Study ID Numbers: CMEX839BDE01
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action