Atrial Fibrillation Feasibility Certoparin Trial - AFFECT - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 13, 2005

Last Updated Date

March 20, 2008

Start Date ^†

April 2005

Current Primary Outcome Measures ^†

Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00171769 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Atrial Fibrillation Feasibility Certoparin Trial - AFFECT

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

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

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment

Condition ^†

Persistent Nonvalvular Atrial Fibrillation

Intervention ^†

Drug: Certoparin

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

200

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States, Germany

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00171769

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Novartis

Collaborators ^††

Investigators ^†

Study Director:

novartis pharmaceuticals

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

March 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.