| CTRI Number |
CTRI/2009/091/000460 [Registered on: 21/07/2009] |
| Last Modified On: |
13/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Other |
Public Title of Study
Modification(s)
|
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery |
Scientific Title of Study
Modification(s)
|
A Multinational, Multicenter, Randomized, Double-Blind study Comparing the Efficacy and Safety of AVE5026 with enoxaparin for the Prevention of Venous Thromboembolism in Patients Undergoing Hip Fracture Surgery (SAVE HIP 2) |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| EFC10343 |
Protocol Number |
| NCT00721760 |
ClinicalTrials.gov |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
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| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
Modification(s)
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| Name |
Dr Josemund Menezes |
| Designation |
|
| Affiliation |
|
| Address |
54/A, Sir Mathuradas Vasanji Road
Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
022-28278024 |
| Fax |
022-28370936 |
| Email |
Josemund.Menezes@sanofi-aventis.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Josemund Menezes |
| Designation |
|
| Affiliation |
|
| Address |
54/A, Sir Mathuradas Vasanji Road
Andheri East
Mumbai
MAHARASHTRA
400093
India |
| Phone |
022-28278024 |
| Fax |
022-28370936 |
| Email |
Josemund.Menezes@sanofi-aventis.com |
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Source of Monetary or Material Support
Modification(s)
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| Sanofi Synthelabo (India) Limited |
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Primary Sponsor
Modification(s)
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| Name |
Sanofi Synthelabo India Limited |
| Address |
54/A, Sir Mathuradas Vasanji Road, Andheri East |
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
Modification(s)
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|
Countries of Recruitment
Modification(s)
|
India |
|
Sites of Study
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| No of Sites = 9 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr.Bharat Mody |
Centre for Hip & Knee Surgery |
101 Akash Ganga Complex,(above Pizza Hut, beside Vanijaya Bhavan) Race course circle-390007
|
bsmody@youtele.com |
| Dr.Ashish Kumar |
Chatrapati Shahu Maharaj Medical University |
Dept.of Orthopedics,Chowk-226003
Lucknow
UTTAR PRADESH |
drashish_kumar20202@yahoo.com |
| Dr.Sharad Pagare |
Gaurav Accident Hospital |
Old Pandit Colony,Opp.KTHM College,Gangapur Rd.,-422002
Nashik
MAHARASHTRA |
|
| Dr.P.Gopal Reddy |
Global Hospitals |
Global Clinical Research Services Pvt.Ltd.,Lakdi-ka-pool-500004
Hyderabad
ANDHRA PRADESH |
contactus.gcrs@gmail.com |
| Dr.Boddapalli Udayakumar |
King George Hospital |
Dept. of Orthopedics,,Andhra Medical College-530002
|
kumar.udaya52@yahoo.com |
| Dr.Naresh Shetty |
M.S.Ramaiah Hospital |
Gokula Metroplois Clinical Research Centre Basement,M.S.Ramaiah Memorial Hospital MSRIT Post-560054
Bangalore
KARNATAKA |
nareshs8cr@gmail.com |
| Dr.Sushrut Babhulkar |
Shushrut Hospital |
Dept. of Orthopedic,Central Bazaar Rd., Ramdaspeth-440010
Nagpur
MAHARASHTRA |
sushrutbabhulkar@rediffmail.com |
| Dr.Satish Mutha |
Siddhi Nursing Home |
16/121 Anand nagar,near Vakola Police Station, Santacruz (E)-400055
Mumbai
MAHARASHTRA |
muthadhkmn@hotmail.com |
| Dr.Akhil Dadi |
Yashoda Hospital |
Dept. of Orthopedics, behind Harihari Kala Bhavan,S.P.Road-500003
|
akhildadi@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 9 |
| Name of Committee |
Approval Status |
| Ethics Committee of Centre for Knee Surgery |
Approved |
| Excel Soceity Of Medical Science, Institutional Ethics Committee |
Approved |
| Excel Soceity Of Medical Science, Institutional Ethics Committee |
Approved |
| Institutional Ethic Committee, Global Hospitals |
Approved |
| Institutional Ethics Committee of Yashoda Academy of Medical Education & Research |
Approved |
| Institutional Ethics Committee, King George Hospital |
Approved |
| Institutional Ethics Committee, Office of the Research Cell of C.S.M.Medical University |
Approved |
| M.S.Ramaiah Medical college&Teaching Hospital Medical Board;Ethical Review Board |
Approved |
| Sushrut Hospital, Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I824||Acute embolism and thrombosis of deep veins of lower extremity, Venous Thromboembolsim, |
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Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
AVE5026 |
once daily subcutaneous injection for 7 to 10 days after surgery |
| Comparator Agent |
Enoxaparin |
once daily subcutaneous injection for 7 to 10 days after surgery |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
- Standard surgery for fracture of the upper third of the femur including femoral head and neck.
|
|
| ExclusionCriteria |
| Details |
- Estimated time of injury/fracture > 24 hours before admission to hospital
- Any major orthopedic surgery in the 3 months prior to study start
- Multiple trauma affecting more than one organ system
- Deep vein thrombosis or pulmonary embolism within the last 12 months or known post-phlebitic syndrome
- Patients at high risk of bleeding
- Known allergy to heparin, or enoxaparin, or pork products
|
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Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
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Centralized |
Blinding/Masking
Modification(s)
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Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
A composite of any VTE confirmed by a blinded Central
Independent Adjudication Committee (CIAC), and deaths from any cause reported during the
efficacy evaluation period. |
From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first
|
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Secondary Outcome
Modification(s)
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| Outcome |
TimePoints |
Any proximal DVT, symptomatic
distal DVT, non fatal PE, and all cause deaths.
A symptomatic distal DVT will be defined as distal DVT confirmed by appropriate diagnostic tests and associated with consistent signs and symptoms of VTE.
A systematic screening for signs and symptoms of VTE will be performed prior to any diagnostic tests for VTE.
? Initiation of curative anticoagulant or thrombolytic treatment by the investigator after local VTE assessment"
|
From the day of randomization up to Day 11, or up to the day of the mandatory bilateral venography, whichever comes first
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Target Sample Size
Modification(s)
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Total Sample Size="1000"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
Date Missing |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
10/09/2008 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="0"
Months="1"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet available |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Trial will be conducted in 28 countries all over the world. The Indian target -35 patients Indian status. The First subject in India was enrolled on 10th September 2008 |