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

NCT ID: NCT00709904

Last Updated: 2013-06-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 469 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2010-01-31

Brief Summary

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.

Detailed 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.

Conditions

Venous Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Semuloparin extension treatment

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.

Group Type: EXPERIMENTAL

Open-label Semuloparin sodium

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection once daily with an initial dose given 8 hours after surgery

Semuloparin sodium

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection once daily

Placebo extension treatment

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

Group Type: PLACEBO_COMPARATOR

Open-label Semuloparin sodium

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection once daily with an initial dose given 8 hours after surgery

Placebo (for Semuloparin sodium)

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component

Subcutaneous injection once daily

Interventions

Open-label Semuloparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection once daily with an initial dose given 8 hours after surgery

Intervention Type: DRUG

Placebo (for Semuloparin sodium)

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml prefilled syringe strictly identical in appearance containing the same volume but without active component

Subcutaneous injection once daily

Intervention Type: DRUG

Semuloparin sodium

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe

Subcutaneous injection once daily

Intervention Type: DRUG

Other Intervention Names

AVE5026; AVE5026

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William D. Fisher, MD

Role: PRINCIPAL_INVESTIGATOR

McGill University Health Centre, Montreal, Quebec, Canada

Alexander G. Turpie, MD

Role: STUDY_CHAIR

HHS-General Hospital, Hamilton, Ontario, Canada

Locations

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Sanofi-Aventis Administrative Office

Minsk, , Belarus

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Santiago, , Chile

Sanofi-Aventis Administrative Office

Shangaï, , China

Sanofi-Aventis Administrative Office

Bogotá, , Colombia

Sanofi-Aventis Administrative Office

Cairo, , Egypt

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Vilnius, , Lithuania

Sanofi-Aventis Administrative Office

México, , Mexico

Sanofi-Aventis Administrative Office

Lima, , Peru

Sanofi-Aventis Administrative Office

Moscow, , Russia

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Sanofi-Aventis Administrative Office

Kiev, , Ukraine

Countries

United States; Belarus; Canada; Chile; China; Colombia; Egypt; India; Lithuania; Mexico; Peru; Russia; South Africa; South Korea; Turkey (Türkiye); Ukraine

References

Fisher WD, Agnelli G, George DJ, Kakkar AK, Lassen MR, Mismetti P, Mouret P, Turpie AG. Extended venous thromboembolism prophylaxis in patients undergoing hip fracture surgery - the SAVE-HIP3 study. Bone Joint J. 2013 Apr;95-B(4):459-66. doi: 10.1302/0301-620X.95B4.30730.

Reference Type: RESULT

PMID: 23539696 (View on PubMed)

Other Identifiers

2007-007947-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10636

Identifier Type: -

Identifier Source: org_study_id