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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007944-80 | EudraCT Number |
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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.
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:
Mandatory bilateral venography of the lower limbs had to be performed 7 to 11 days after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semuloparin | Experimental | 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 |
|
| Enoxaparin | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semuloparin sodium | Drug | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced Venous Thromboembolism Event [VTE] or Death From Any Cause | VTE included any proximal or distal Deep Vein Thrombosis [DVT] (symptomatic or not) and non-fatal Pulmonary Embolism [PE] as confirmed by a Central Independent Adjudication Committee [CIAC] after review of mandatory bilateral venograms and diagnostic tests for VTE. All-cause deaths included fatal PE and deaths for other reason than PE. | From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experienced "Major" VTE or All-cause Death | "major" VTE included any proximal DVT, symptomatic distal DVT and nonfatal Pulmonary Embolism (PE) as confirmed by the CIAC. | From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first |
| Percentage of Participants Who Experienced Clinically Relevant Bleedings |
| Measure | Description | Time Frame |
|---|---|---|
| Overview of deaths | All deaths were centrally and blindly reviewed by the CIAC and classified as fatal PE, fatal bleeding, cardiovascular death or other based on relevant documentation (e.g. autopsy report). | From first study drug injection up to 3 days after last study drug injection |
| Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA] |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
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| Name | Affiliation | Role |
|---|---|---|
| Patrick MOURET, MD | Orthopädische Klinik, Stätische Klinik, Gotenstrasse 6-8, Frankfurt Höechst, 65929 Frankfurt, Germany | Principal Investigator |
| Alexander G. TURPIE, MD | HHS-General Hospital, Hamilton, Ontario, Canada | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sanofi-Aventis Administrative Office | Bridgewater | New Jersey | 08807 | United States | ||
| Sanofi-Aventis Administrative Office |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22429800 | Result | 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. |
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| Enoxaparin sodium | Drug | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection |
|
|
| Placebo | 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 |
|
Bleedings were centrally and blindly reviewed by the CIAC and classified as:
|
| From first study drug injection up to 3 days after last study drug injection |
| Percentage of Participants Who Required the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment | Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment was defined from investigator's answer to the question "was the subject treated for VTE?" asked after the diagnostic tests for suspected VTE and after the mandatory venography. | From randomization up to 10 days after surgery or the day of mandatory venography, whichever came first |
PCSA values are abnormal values considered medically important by the Sponsor according to predefined criteria based on literature review. Threshold for platelet counts was defined as <100 Giga/L. |
| From first study drug injection up to 3 days after last study drug injection |
| Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities [PCSA] | Thresholds were defined as follows:
Cases with ALAT >3 ULN and TB >2 ULN (not necessarily concomitant) were evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria. | From first study drug injection up to 3 days after last study drug injection |
| 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 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C542814 | AVE 5026 |
| C000711671 | enoxaparin sodium |
| D017984 | Enoxaparin |
| ID | Term |
|---|---|
| D006495 | Heparin, Low-Molecular-Weight |
| D006493 | Heparin |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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