Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

East Hanover, New Jersey 07936


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


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


Study is Available At:


Original ID:

CMEX839BDE01


NCT ID:

NCT00171769


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

Phase 3


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

Germany: Federal Institute for Drugs and Medical Devices


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

200


Enrollment Type:


Overall Contact Information

Official Name:novartis pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:April 2005
Primary Completion Date:August 2006
Primary Completion Type:Actual
Verification Date:February 2017
Last Changed Date:February 21, 2017
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Primary Outcome
Measure:Safety measures including reporting of serious adverse events and adverse events, including vascular and neurological events
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Certoparin

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation:Tebbe U, Oeckinghaus R, Appel KF, Heuer H, Haake H, Eggers E, Seidel K, Adams J, Harenberg J. AFFECT: a prospective, open-label, multicenter trial to evaluate the feasibility and safety of a short-term treatment with subcutaneous certoparin in patients with persistent non-valvular atrial fibrillation. Clin Res Cardiol. 2008 Jun;97(6):389-96. doi: 10.1007/s00392-008-0644-y.
PMID:18322636

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.