Atrial Fibrillation Feasibility Certoparin Trial - AFFECT - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00171769

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 III

Genetics Home Reference related topics: Brugada syndrome familial atrial fibrillation short QT syndrome

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment
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

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

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

Study ID Numbers:	CMEX839BDE01
Study First Received:	September 13, 2005
Last Updated:	March 20, 2008
ClinicalTrials.gov Identifier:	NCT00171769
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Heart Diseases
Heparin, Low-Molecular-Weight
Atrial Fibrillation
Certoparin
Arrhythmias, Cardiac

Additional relevant MeSH terms:

Anticoagulants
Pathologic Processes
Therapeutic Uses

Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009