Evaluation of AVE5026 as Compared to Enoxaparin for the Prevention of Thromboembolism in Patients Undergoing Total Hip Replacement Surgery

NCT ID: NCT00697099

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2326 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-06-30
• Study Completion Date: 2009-06-30

Brief Summary

The primary objective was to compare the efficacy of once daily [q.d.] subcutaneous [s.c.] injections of Semuloparin sodium (AVE5026) with q.d. s.c. injections of enoxaparin for the prevention of Venous Thromboembolic Events [VTE] in patients undergoing elective total hip replacement surgery.

The secondary objectives were to evaluate the safety of AVE5026 in patients undergoing elective total hip replacement surgery, and to document AVE5026 exposure in this population.

Detailed Description

Randomization had to take place just prior the first study drug injection (randomization ratio 1:1).

The total duration of observation per participant was 35-42 days from surgery broken down as follows:

• 7 to 10-day double-blind treatment period;
• 28 to 35-day follow-up period.

Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.

Conditions

Venous Thromboembolism

Study Design

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

Study Groups

Semuloparin

Semuloparin sodium 20 mg (10 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given 8 hours after surgery

Placebo for Enoxaparin sodium prior to surgery according to local standard for Enoxaparin and 12 hours after surgery to maintain the blind

Group Type: EXPERIMENTAL

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

Placebo

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe strictly identical in appearance but without active component

Subcutaneous injection

Enoxaparin

Enoxaparin sodium 40 mg (20 mg if Severe Renal Impairment [SRI]) once daily for 7-10 days with an initial dose given prior to or 12 hours after surgery according to local standard for Enoxaparin sodium

Placebo for Semuloparin sodium 8 hours after surgery to maintain the blind

Group Type: ACTIVE_COMPARATOR

Enoxaparin 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

Placebo

Intervention Type: DRUG

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe strictly identical in appearance but without active component

Subcutaneous injection

Interventions

Semuloparin sodium

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

Subcutaneous injection

Intervention Type: DRUG

Enoxaparin sodium

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

Subcutaneous injection

Intervention Type: DRUG

Placebo

0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe strictly identical in appearance but without active component

Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

AVE5026; Lovenox®

Eligibility Criteria

Inclusion Criteria

• Elective total hip replacement surgery or a revision of at least one component of a prosthesis implanted ≥ 6 months prior to study entry.

Exclusion Criteria

• Any major orthopedic surgery in the 3 months prior to study start;
• Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome;
• High risk of bleeding;
• Known allergy to heparin or enoxaparin;
• Any contra-indications 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

Patrick MOURET, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopädische Klinik, Stätische Klinik, Gotenstrasse 6-8, Frankfurt Höechst, 65929 Frankfurt, Germany

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

Buenos Aires, , Argentina

sanofi-aventis Australia & New Zealand administrative office

Macquarie Park, New South Wales, Australia

Sanofi-Aventis Administrative Office

Minsk, , Belarus

Sanofi-Aventis Administrative Office

Laval, , Canada

Sanofi-Aventis Administrative Office

Santiago, , Chile

Sanofi-Aventis Administrative Office

Bogotá, , Colombia

Sanofi-Aventis Administrative Office

Prague, , Czechia

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Sanofi-Aventis Administrative Office

Tallinn, , Estonia

Sanofi-Aventis Administrative Office

Helsinki, , Finland

Sanofi-Aventis Administrative Office

Berlin, , Germany

Sanofi-Aventis Administrative Office

Athens, , Greece

Sanofi-Aventis Administrative Office

Mumbai, , India

Sanofi-Aventis Administrative Office

Milan, , Italy

Sanofi-Aventis Administrative Office

México, , Mexico

Sanofi-Aventis Administrative Office

Lysaker, , Norway

Sanofi-Aventis Administrative Office

Lima, , Peru

Sanofi-Aventis Administrative Office

Makati City, , Philippines

Sanofi-Aventis Administrative Office

Warsaw, , Poland

Sanofi-Aventis Administrative Office

Bucharest, , Romania

Sanofi-Aventis Administrative Office

Moscow, , Russia

Sanofi-Aventis Administrative Office

Brastislava, , Slovakia

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Sanofi-Aventis Administrative Office

Bromma, , Sweden

Sanofi-Aventis Administraive Office

Taipei, , Taiwan

Sanofi-Aventis Administrative Office

Bangkok, , Thailand

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Sanofi-Aventis Administrative Office

Kiev, , Ukraine

Countries

United States; Argentina; Australia; Belarus; Canada; Chile; Colombia; Czechia; Denmark; Estonia; Finland; Germany; Greece; India; Italy; Mexico; Norway; Peru; Philippines; Poland; Romania; Russia; Slovakia; South Africa; Spain; Sweden; Taiwan; Thailand; Turkey (Türkiye); Ukraine

References

Lassen MR, Fisher W, Mouret P, Agnelli G, George D, Kakkar A, Mismetti P, Turpie AG; SAVE Investigators. Semuloparin for prevention of venous thromboembolism after major orthopedic surgery: results from three randomized clinical trials, SAVE-HIP1, SAVE-HIP2 and SAVE-KNEE. J Thromb Haemost. 2012 May;10(5):822-32. doi: 10.1111/j.1538-7836.2012.04701.x.

Reference Type: RESULT

PMID: 22429800 (View on PubMed)

Other Identifiers

2007-007944-80

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

EFC10342

Identifier Type: -

Identifier Source: org_study_id