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 - AFFECT

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-002888-24-DE
• Date of registration: 09/09/2005
• Prospective Registration: No
• Primary sponsor: Novartis Pharma GmbH
• Public 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 - AFFECT
• Scientific 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 - AFFECT
• Date of first enrolment: 15/03/2005
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-002888-24
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion criteria:
•women or men =18 years
•persistent AF (electrical cardioversion is planned)
•written informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
•unsuccessful cardioversion in the past
•UFH or LMWH for more than 48 hours before start of study drug
•current oral anticoagulation
•indication for medical cardioversion
•acute clinical signs of venous thromboembolism
•platelet count <100000/µL
•body weight <60 kg
•known hypersensitivity to certoparin or heparin
•recent (within the last 3 months) or active bleeding
•acute (or suspicion of) stroke, intracranial bleeding or cerebral aneurysm
•severe uncontrolled hypertension
•known severe hepatic or renal insufficiency or serum creatinine >2 mg/dL
•known pregnancy or breastfeeding or women of childbearing potential without reliable contraception
•participation in another investigative drug study within the last 30 days



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Atrial fibrillation
MedDRA version: M15 Level: LLT Classification code 10003658

Intervention(s)

Trade Name: Mono-Embolex 8000 I.E. Therapie
Product Name: Mono-Embolex 8000 I.E. Therapie
Pharmaceutical Form: Injection*
INN or Proposed INN: Certoparin
Current Sponsor code: MEX839
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 8000-

Primary Outcome(s)

Main Objective: Primary objective is to document the feasibility and safety of short-term treatment with a fixed, body weight-independent certoparin regimen (8000 U anti-Xa twice daily) in patients with persistent nonvalvular AF.

Primary end point(s): This study is designed to provide data about feasibility and safety of short-term treatment with certoparin in patients with persistent nonvalvular AF and indication for electrical cardioversion. The purpose of this trial is not confirmatory, it aims to describe the experience gained. Therefore, no primary endpoint will be defined and analysis will be performed by descriptive means only.

Special emphasis will be laid on the documentation of cerebral-ischemic neurological events (stroke, transient ischemic attacks), venous thromboembolism (DVT, pulmonary embolism), bleeding complications (classified as minor or major).

Secondary Objective: Coagulation parameters will be determined during certoparin treatment.

Secondary ID(s)

CP-AF-1