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1 Clinical Trial Details (PDF Generation Date :- Mon, 11 Mar :03:17 GMT) CTRI Number CTRI/2007/091/ [Registered on: 19/09/2008] - Last Modified On 05/08/2014 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Once-daily Oral Direct Factor Xa Inhibitor Rivaroxaban in the Long-term Prevention of Recurrent Symptomatic Venous Thromboembolism in Patients With Symptomatic Deep-vein Thrombosis or Pulmonary Embolism. The Einstein-Extension Study Once-daily oral direct factor Xa inhibitor rivaroxaban in the long-term prevention of recurrent symptomatic venous thromboembolism in patients with symptomatic deep-vein thrombosis or pulmonary embolism.the Einstein-Extension study. Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) EudraCT NCT ClinicalTrials.gov Details of Principal Investigator Not Applicable N/A Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Ashish Gawde Phone Fax Country Medical Director Country Medical Director Bayer Pharmaceuticals Private Limited Hiranandani Estate Thane ashish.gawde@bayer.com Details Contact Person (Public Query) Dr Ashish Gawde Phone Country Medical Director Bayer Pharmaceuticals Private Limited Hiranandani Estate Thane page 1 / 5

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Details of Ethics Committee Fax Source of Monetary or Material Support > Bayer HealthCare AG,D Leverkusen,Germany. Type of Sponsor Primary Sponsor Details Bayer HealthCare AG Bayer HealthCare AG,D Leverkusen,Germany. Edit Delete Bayer HealthCare AG,D Leverkusen,Germany. Edit Delete D Leverkusen,Germany. Pharmaceutical industry-global Johnson & Johnson Pharmaceutical Research & Development, L.L.C. List of Countries of Principal Investigator Dr. S. Surendran Dr S Edwin of Site Site Phone/Fax/ Amrita Institute of medical Science and Research Centre Christian Medical College Dr Pinjala Ramakrishna Nizam Institute of Medical Sciences Dr. Farhad N Kapadia Dr Dhanesh R Kamerkar Dr Rajiv Parakh PD Hinduja National Hospital and Research Center Ruby Hall Clinic Amrita lane,elamakkara PO Not Applicable N/A Vellore, Vellore TAMIL NADU Department of Vascular Surgery Pinjagutta Hyderabad ANDHRA PRADESH sudhi@aims.amrita.edu edwinserina@gmail.co m nims@ap.nic.in Department of Critical Care and Emergency Medicine,Veer Savarkar fkapadia@vsnl.com Marg, Mahim Mumbai Department of Vascular Surgery,40 Sasson Road, Pune Sir Gangaram Hospitals Department of Vascular Surgery,Rajinder Nagar-New Delhi New Delhi DELHI dhaneshk@eth.net rparakh1@yahoo.co.in of Committee Approval Status Date of Approval Is Independent Ethics Committee? ethics Committe, Sir Gangaram Hospitals ethics Committe. Poona Medical Research Approved 17/10/2007 No Approved 31/07/2007 No page 2 / 5

3 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Foundation Institutional ethics Committe, Amrita Institute of medical Science Institutional ethics Committe, Nizam Institute of Medical Sciences Institutional Reveiw Board, Christian Medical College, Vellore The Clinical Research & Ethics Committee, PD Hinduja National Hospital and Research Center Status Approved/Obtained Health Type Patients Approved No Date Specified Not Available Approved No Date Specified Not Available Approved 23/02/2008 No Approved 11/02/2008 No Date No Date Specified Condition Venous Thromboembolism Type Details Intervention Rivaroxaban (BAY ) Patients randomized to rivaroxaban will receive rivaraoxaban 20 mg once-daily. Route of administration: oral (tablet) Duration of treatment: 6 or 12 months (determined individually before randomization). The study was terminated once a total of at least 30 confirmed recurrent thromboembolic events had been reached. If the number of events was reached before all subjects had completed the intended study treatment duration, the last included subjects had to be treated until they reached a total treatment duration of at least 3 months. Comparator Agent Placebo Patients allocated to placebo will receive a matching placebo tablet once daily. Route of administration: oral (tablet) Duration of treatment: 6 or 12 months (determined individually before randomization). The study was terminated once a total of at least 30 confirmed recurrent thromboembolic events had been reached. If the number of events was reached before all subjects had completed the intended study treatment duration, the last page 3 / 5

4 Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Age From Age To Gender Details Details Inclusion Criteria included subjects had to be treated until they reached a total treatment duration of at least 3 months. Bulk batch Inclusion Criteria: - Patients with confirmed symptomatic PE or DVT who have been treated for 6 or 12 months with VKA or rivaroxaban Exclusion Criteria Participant, Investigator and Outcome Assessor Blinded Exclusion Criteria: - Legal lower age limitations (country specific) - Indication for VKA other than DVT and/or PE - Patients in whom anticoagulant treatment for their index PE or DVT should be continued - Childbearing potential without proper contraceptive measures, pregnancy or breast feeding. Proper contraceptive measures are defined as a method of contraception with a failure rate 1 % during the course of the study (including the observational ). These methods of contraception according to the note for guidance on non-clinical safety studies for the conduct of human trials for pharmaceuticals (CPMP/ICH/286/95, modification) include consistent and correct use of hormone containing implants and injectables, combined oral contraceptives, hormone containing intrauterine devices, surgical sterilization, sexual abstinence and vasectomy Primary Outcome Outcome Timepoints Symptomatic recurrent VTE, i.e., the composite of recurrent DVT or fatal or non-fatal PE Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Time-to-first major bleeding Clinically relevant bleeding All death and other vascular events Total Sample Size=1300 Sample Size from =19 28/02/ /01/2007 Years=1 Months=0 Days=0 Completed page 4 / 5

5 Powered by TCPDF ( Recruitment Status of Trial () Publication Details Brief Summary Completed EINSTEIN investigators, Bauersachs R,Berkowitz SD, Brenner B,Buller HR, Decousus H,Gallus A Raskob GE,Segers A,Verhamme p,agnelli G, Bounameaux H,Cohen A,Davidson BL,Pisymptomatic venous thromboembolism. N Engl J Med Dec 23;363(26): doi: This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT or PE who completed 6 or 12 months of treatment with rivaroxaban or VKA are eligible for this trial (Einstein-Extension study). Goal: To evaluate whether rivaroxaban is better than placebo in the long-term prevention of recurrent symptomatic venous thromboembolism (VTE) in patients with symptomatic deep-vein thrombosis (DVT) or pulmonary embolism (PE) who completed 6 or 12 months of treatment with vitamin K antagonist (VKA) or rivaroxaban. (FPFV in : 17 May 2008) page 5 / 5