Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-007947-28 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The total duration of observation per participant is 56-63 days from surgery broken down as follows:
Mandatory bilateral venography of the lower limbs is to be performed between 19 and 24 days after randomization.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Semuloparin extension treatment | Experimental | 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. |
|
| Placebo extension treatment | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Open-label Semuloparin sodium | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience Venous Thromboembolism Events (VTE) or Death From Any Cause During the Extension Treatment Period | VTE include any 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 suspected VTE. All-cause deaths include fatal PE and deaths for other reason than PE. | From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Experience "Major" VTE or Death From Any Cause | "Major" VTE include any proximal DVT, symptomatic distal DVT and non-fatal PE as confirmed by the CIAC. | From randomization up to 24 days after randomization or the day of mandatory venography, whichever comes first |
| Percentage of Participants Who Experience Clinically Relevant Bleedings During the Extension Treatment Period |
| Measure | Description | Time Frame |
|---|---|---|
| Overview of Reported Bleeding Adverse Event | Analysis periods are defined as follows:
| From 1st study drug injection up to 3 days after last study drug injection |
Inclusion Criteria:
In the run-in phase:
In the double-blind phase following the run-in phase:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| William D. Fisher, MD | McGill University Health Centre, Montreal, Quebec, Canada | 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 |
|---|---|---|---|
| 23539696 | Result | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Placebo (for Semuloparin sodium) | 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 |
|
| Semuloparin sodium | Drug | 0.4 mL (0.2 mL if SRI) solution in ready-to-use 0.5 ml pre-filled syringe Subcutaneous injection once daily |
|
|
Bleedings are centrally and blindly reviewed by the CIAC and classified as: "major" (fatal, in a critical area/organ, causing a post-operative drop in hemoglobin ≥2 g/dL or requiring post-operative transfusion ≥2 units of blood, leading to an invasive diagnostic or therapeutic intervention, or associated with circulatory decompensation); "clinically relevant non-major" (skin hematoma or epistaxis requiring surgical/medical intervention/treatment, macroscopic hematuria, or overt bleeding requiring specific attention by health care professional); "Non-clinically relevant bleeding". |
| From 1st study drug injection in the extension treatment period up to 3 days after last study drug injection |
| Percentage of Participants Who Require the Initiation of Curative Anticoagulant or Thrombolytic Treatment After VTE Assessment During the Extension Treatment Period | Initiation of curative anticoagulant or thrombolytic treatment after VTE assessment is 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 24 days after randomization or the day of mandatory venography, whichever comes first |
| Overview of Deaths | The same analysis periods as defined for the previous outcome measure are used. In addition deaths during the extension treatment period are 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 1st study drug injection up to 3 days after last study drug injection |
| Platelets Count: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) | PCSA are abnormal values considered medically important by the Sponsor according to pre-defined criteria based on literature review. Threshold for platelets count was defined as <100 Giga/L. The analysis periods as previously defined are used (see outcome measure 5). | From 1st study drug injection up to 3 days after last study drug injection |
| Liver Function: Percentage of Participants With Potentially Clinically Significant Abnormalities (PCSA) | Thresholds are defined as follows:
Cases with ALT >3 ULN and TB >2 ULN (not necessarily concomitant) are evaluated by a blinded independent adjudicator to determine if they met Hy's law criteria. The analysis periods as previously defined are used (see outcome measure 5). | From 1st study drug injection up to 3 days after last study drug injection |
| 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 |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C542814 | AVE 5026 |
Not provided
Not provided
Not provided