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Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00171769
First received: September 13, 2005
Last updated: August 31, 2010
Last verified: March 2008
History of Changes
  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: 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:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00171769     History of Changes
Other Study ID Numbers: CMEX839BDE01
Study First Received: September 13, 2005
Last Updated: August 31, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Certoparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013