Evaluation of AVE5026 as Compared to Placebo for the Extended Prophylaxis of Venous Thromboembolism in Patients Having Undergone Hip Fracture Surgery (SAVE-HIP3)

Sanofi

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Semuloparin sodium; Drug: Placebo (for Semuloparin sodium); Drug: Open-label Semuloparin sodium

Study type: Interventional

Funder types: Industry

Identifiers

NCT00709904

EFC10636

2007-007947-28 (EudraCT Number)

Details and patient eligibility

About

The primary objective is to evaluate the efficacy of once daily (QD) subcutaneous (SC) injections of Semuloparin sodium (AVE5026) versus placebo for 3 additional weeks following an initial 7 to 10-day venous thromboprophylaxis with open-label AVE5026 in patients having undergone hip fracture surgery.

The secondary objective is to evaluate the safety of extended AVE5026 administration.

Full description

The total duration of observation per participant is 56-63 days from surgery broken down as follows:

• 7 to 10-day initial treatment period with open-label Semuloparin sodium;
• Randomization;
• 19 to 23-day double-blind treatment period with Semuloparin sodium or placebo;
• 30-day follow-up period.

Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.

Enrollment: 469 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• In the run-in phase:

  • Standard surgery for fracture of the upper third of the femur, including femoral head and neck

• In the double-blind phase following the run-in phase:

  • Completion of the run-in phase without permanent treatment discontinuation

Exclusion criteria

• Any major orthopedic surgery within 3 months prior to enrolment;
• Deep vein thrombosis or pulmonary embolism within the last 12 months, or known post-phlebitic syndrome;
• High risk of bleeding;
• Known hypersensitivity to heparins;
• Any contraindication to the performance of venography;
• End stage renal disease or patient on dialysis

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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469 participants in 2 patient groups, including a placebo group

Semuloparin extension treatment

Experimental group

Description:

Extension treatment with Semuloparin sodium 20 mg (10 mg if SRI) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days.

Treatment:

Drug: Open-label Semuloparin sodium

Drug: Semuloparin sodium

Placebo extension treatment

Placebo Comparator group

Description:

Extension treatment with placebo (for Semuloparin sodium) for 19-23 days following initial treatment with open-label Semuloparin 20 mg (10 mg if SRI) for 7-10 days

Treatment:

Drug: Open-label Semuloparin sodium

Drug: Placebo (for Semuloparin sodium)