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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2004-002888-24-DE
Enrollment
Unknown
Registered
2005-09-09
Start date
2005-03-15
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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 uni

Sponsors

Novartis Pharma GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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 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

Design outcomes

Primary

MeasureTime frame
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.;Secondary Objective: Coagulation parameters will be determined during certoparin treatment.;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).—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026