EUCTR2007‐003746‐15‐DE.

Trial name or title	Prospective randomised open study on the comparison of fondaparinux with the low‐molecular‐weight heparin enoxaparin in patients undergoing femoro‐distal venous bypass operation
Methods	Randomised controlled trial
Participants	Periperal arterial occlusive disease Fontaine IIb to IV Possibility of venous bypass reconstruction with intended oral anticoagulation Women with childbearing potential were included only when they were using correctly and consistently a highly effective method of birth control (i.e. Pearl‐Index < 1) during the study. Regarded as highly effective were sterilised women, vasectomised partner, combined oral contraceptives and hormone‐eluting IUDs.
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 Concentration number: 2.5/0.5 Trade name: Clexane Product name: Clexane Pharmaceutical form: anticoagulant and preservative solution for blood INN or proposed INN: enoxaparin‐sodium Concentration unit: mg/mL Concentration number: 100
Outcomes	Primary endpoint(s): Efficacy: postoperative bypass patency Safety: major bleeding complications
Starting date	27 March 2008
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