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Clinical Trials/EUCTR2004-002888-24-DE
EUCTR2004-002888-24-DE
Active, not recruiting
Not Applicable

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

ovartis Pharma GmbH0 sitesSeptember 9, 2005
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DrugsMono-Embolex 8000 I.E. Therapie

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ovartis Pharma GmbH
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 9, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
ovartis Pharma GmbH

Eligibility 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

Outcomes

Primary Outcomes

Not specified

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