Venous Thromboembolism Clinical Trial
— TREKOfficial title:
A Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel Group, Dose Response Study of Subcutaneous AVE5026 With an Enoxaparin Calibrator Arm in the Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery
The primary objective was to demonstrate the dose-response of Semuloparin sodium (AVE5026)
for the prevention of Venous Thromboembolism [VTE] in patients undergoing total knee
replacement [TKR] surgery.
Secondary objectives were to evaluate the safety (incidence of major bleeding) of AVE5026,
to document the efficacy and safety of AVE5026 post-operative regimens, and to assess the
pharmacokinetic parameters of AVE5026.
Status | Completed |
Enrollment | 705 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patient scheduled to undergo elective total knee replacement or revision of a primary procedure performed = 6 months prior to study entry. Exclusion Criteria: - Any major orthopedic surgery in the 3 months prior to study entry; - Clinical signs or symptoms of DVT or PE within the last 12 months or known post-phlebitic syndrome; - Known sensitivity to iodine or contrast dyes; - Recent stroke or myocardial infarction; - High risk of bleeding; - Treatment with other anti-thrombotic agents within 7 days prior to surgery; - Any contra-indication to Unfractionated Heparin or Low Molecular Weight Heparin; - Pregnant or nursing woman, or woman of childbearing potential who is not using an effective contraceptive method. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Argentina | Sanofi-Aventis Administrative Office | Buenos Aires | |
Bulgaria | Sanofi-Aventis Administrative Office | Sofia | |
Chile | Sanofi-Aventis Administrative Office | Santiago | |
Colombia | Sanofi-Aventis Administrative Office | Santafe de Bogota | |
Denmark | Sanofi-Aventis Administrative Office | Horsholm | |
Finland | Sanofi-Aventis Administrative Office | Helsinki | |
Greece | Sanofi-Aventis Administrative Office | Athens | |
Malaysia | Sanofi-Aventis Administrative Office | Kuala Lumpur | |
Mexico | Sanofi-Aventis Administrative Office | Mexico | |
Norway | Sanofi-Aventis Administrative Office | Lysaker | |
Philippines | Sanofi-Aventis Administrative Office | Makati City | |
Poland | Sanofi-Aventis Administrative Office | Warszawa | |
Portugal | Sanofi-Aventis Administrative Office | Porto Salvo | |
Romania | Sanofi-Aventis Administrative Office | Bucuresti | |
Russian Federation | Sanofi-Aventis Administrative Office | Moscow | |
Sweden | Sanofi-Aventis Administrative Office | Bromma | |
Taiwan | Sanofi-Aventis Administrative Office | Taipei | |
Thailand | Sanofi-Aventis Administrative Office | Bangkok | |
Turkey | Sanofi-Aventis Administrative Office | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Argentina, Bulgaria, Chile, Colombia, Denmark, Finland, Greece, Malaysia, Mexico, Norway, Philippines, Poland, Portugal, Romania, Russian Federation, Sweden, Taiwan, Thailand, Turkey,
Lassen MR, Dahl OE, Mismetti P, Destrée D, Turpie AG. AVE5026, a new hemisynthetic ultra-low-molecular-weight heparin for the prevention of venous thromboembolism in patients after total knee replacement surgery--TREK: a dose-ranging study. J Thromb Haemo — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Deaths | All deaths were centrally and blindly reviewed by the CIAC and classified as "Fatal PE", "PE not excluded", "Fatal bleeding" and "Death not associated with VTE or bleeding" based on relevant documentation (e.g. autopsy report). | From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) | Yes |
Other | Platelets Count: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] | PCSA 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 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) | Yes |
Other | Liver Function: Number of Participants With Potentially Clinically Significant Abnormalities [PCSA] | Thresholds were defined as follows: Alanine Aminotransferase [ALAT] >3 Upper Normal Limit [ULN]; Total Bilirubin [TB] =34 µmol/L; ALAT =3 ULN and TB =34 µmol/L. |
From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) | Yes |
Primary | Number of Participants Who Experienced Venous Thromboembolism Event (VTE) or VTE-related Death | VTE included any Deep Vein Thrombosis [DVT] identified on mandatory venography of the lower limbs; symptomatic DVT and/or non-fatal pulmonary embolism [PE] before mandatory examination; VTE related deaths included fatal PE or deaths which could not be attributed to a documented cause and for which PE could not be ruled out. All events were to be confirmed by a Central Independent Adjudication Committee [CIAC] based on venographies, scheduled or unscheduled, and other available diagnostic tests (ultrasonography, ventilation/perfusion lung scan, pulmonary angiography, autopsy report, etc). | From surgery to Day 11 or the day of mandatory venography, whichever came first | No |
Secondary | Number of Participants Who Experienced DVT | From surgery up to Day 11 or the day of mandatory venography, whichever came first | No | |
Secondary | Number of Participants Who Experienced Symptomatic VTE | Symptomatic VTE included: suspected DVT confirmed by the CIAC based on compression ultrasonography or venography; suspected PE confirmed by the CIAC based on perfusion/ventilation lung scan, pulmonary angiography or spiral computerized tomography. |
From surgery up to Day 11 or the day of mandatory venography, whichever came first | No |
Secondary | Number of Participants Who Experienced Bleedings | Bleedings were centrally and blindly reviewed by the CIAC and classified as: "Major" (fatal bleeding, bleeding that was retroperitoneal or intracranial or that involved any other critical organ (e.g. eye, adrenal gland, pericardium or spine), surgical site bleeding leading to intervention, non-surgical site bleeding requiring surgical intervention or with a bleeding index =2); "Minor" (overt bleeding considered more than expected but not meeting the criteria for major bleeding); "Criteria for bleeding event not satisfied" (not meeting the criteria for major or minor bleeding). |
From 1st study drug injection up to 3 days after last study drug injection (median duration of approximately 11 days) | Yes |
Secondary | Number of Participants Who Required 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 answers to questions asked after diagnostic tests for suspected VTE and/or the mandatory venography. | From surgery up to Day 11 or the day of mandatory venography, whichever came first | No |
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