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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003746-15-DE
Enrollment
Unknown
Registered
2008-02-27
Start date
2008-03-27
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

Patients with underlying peripheral occlusive vascular disease undergoing bypass surgery MedDRA version: 9.1 Level: HLGT Classification code 10003184 Term: Vascular therapeutic procedures

Interventions

Trade Name: Arixtra Product Name: Arixtra Pharmaceutical Form: Anticoagulant and preservative solution for blood INN or Proposed INN: Fondaparinux-Sodium Concentration unit: mg/ml milligram(s)/millili

Sponsors

Ammerland-Klinik Westerstede
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Main Objective: Comparison of Enoxaparin vs. Arixtra in pateints undergoing peripheral bypass surgery concerning patency-rates ;Secondary Objective: Comparison of Enoxaparin vs. Arixtra in patients undergoing peripheral bypass surgery concerning bleedig complications;Primary end point(s): Efficacy: postoperative bypass patency Safety: major bleeding complications—

Countries

Germany

Outcome results

None listed

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