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Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00171769
First Posted: September 15, 2005
Last Update Posted: February 23, 2017
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.
Information provided by:
Novartis
  Purpose
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 Intervention Phase
Persistent Nonvalvular Atrial Fibrillation Drug: Certoparin Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

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

Estimated Enrollment: 200
Study Start Date: April 2005
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
  Eligibility

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
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00171769


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

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00171769     History of Changes
Other Study ID Numbers: CMEX839BDE01
First Submitted: September 13, 2005
First Posted: September 15, 2005
Last Update Posted: February 23, 2017
Last Verified: February 2017

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