prospective randomized open study on the comparison of fondaparinux with the low-molecular-weight heparin enoxaparin in patients undergoing femoro-distal venous bypass operatio

• Conditions: Patients with underlying peripheral occlusive vascular disease undergoing bypass surgery; MedDRA version: 9.1Level: HLGTClassification code 10003184Term: Vascular therapeutic procedures

• Registration Number: EUCTR2007-003746-15-DE
• Lead Sponsor: Ammerland-Klinik Westerstede

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-27
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

periperal arterial occlusive disease fontaine IIb - IV
possibility of venous bypass reconstruction with intended oral antikoagulation
women with childbearing potential are only included when using correctly and consistently a highly effective method of birth control (i. e. Pearl-Index less than 1) during the study. As highly effective are regarded:
sterilized women
vasectomised partner
combined oral contraceptives
hormone-eluting IUDs

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

progressive renal insufficiency (Creatinine-Clearance < 50 ml/min)
known hypersensitivity against Fondaparinux or Enoxaparin
known contraindications against either IMP
contraindication against oral antikoagulation
age < 18 years
pregnancy
women of childbearing potential using a method of birth control other than described under E.3
known active gastric ulcers

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified