Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

This study has been completed.

First Received on September 13, 2005. Last Updated on August 31, 2010 History of Changes

Sponsor:	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

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:

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

MedlinePlus related topics: Atrial Fibrillation

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 February 09, 2012