Comparative Investigation of Low Molecular Weight (LMW) Heparin/Edoxaban Tosylate (DU176b) Versus (LMW) Heparin/Warfarin in the Treatment of Symptomatic Deep-Vein Blood Clots and/or Lung Blood Clots.
- Conditions
- Acute symptomatic proximal deep-vein thrombosis and/or symptomatic pulmonary embolism
- Registration Number
- CTRI/2010/091/000317
- Lead Sponsor
- Daiichi Sankyo Pharma Development
- Brief Summary
This is a Phase 3, multi-national, multi-center, randomized, double-blind, matching placebo, parallel-group (2 treatment groups), non-inferiority study for efficacy. The maximum treatment period for any individual subject after randomization will be 12 months. While 12 months of treatment are planned, mitigating factors related to the subject?s clinical status will likely influence the total duration of treatment a given subject actually receives. Nevertheless, it is planned that all subjects will be administered a minimum of three months treatment consistent with current American College of Chest Physicians (ACCP) Guidelines. It is anticipated that approximately 10% of subjects will discontinue treatment after 3 months, an additional 40% will discontinue after 6 months, and 50% will complete the entire 12 months of treatment. Treatment durations will be monitored during the study, and the Steering Management Coordinating Committee (SMCC) will take appropriate action to ensure that an approximate proportion of subjects complete the treatment durations as indicated. Regardless of the total duration of study drug treatment actually received, efficacy and safety data will be collected on all subjects, including those who temporarily interrupt or permanently discontinue study drug, during the entire 12-month period following randomization. For all subjects, contacts (visits or phone calls) are scheduled at regular time points. During these contacts, the treatment and clinical course of the subject will be evaluated. Subjects with suspected efficacy or safety endpoints will undergo confirmatory testing. All subjects, including those who temporarily interrupt or permanently discontinue study drug, will be expected to have the following: - A Month 12 visit which is critical for the modified intent to treat (mITT) analysis of efficacy, - A safety follow-up visit approximately 1 month after the last dose of study drug. In this context, last dose means last dose before permanent study drug discontinuation (premature or at the scheduled end of treatment). Globally approximately 7,500 subjects will be randomized and in India 1000 subjects are targeted to be enrolled. The date of first patient enrollment in India is May 15, 2010.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 7500
Ages Eligible for Study: 18 Years and older Genders Eligible for Study: Both Accepts Healthy Volunteers: No 1)Male or female subjects older than the minimum legal adult age (country specific); 2)Acute symptomatic proximal DVT and/or symptomatic PE confirmed at the site by appropriate diagnostic imaging; 3)Able to provide written informed consent.
1)Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT and/or PE; 2)More than 48 hours pre-treatment with anticoagulant therapy prior to randomization; 3)Calculated CrCL < 30 mL/min; 4)significant liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or alanine transaminase (ALT) >= 2 times the upper limit of normal (ULN), or total bilirubin (TBL) x 1.5 times the ULN; 5)patients with active cancer for whom long term treatment with (LMW) heparin is anticipated; 6)active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin or warfarin; 7)chronic treatment with non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs); 8)treatment with aspirin in a dosage of more than 100 mg/per day or dual antiplatelet therapy; 9)concurrent treatment with potent P-gp inhibitors; 10)subjects with any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Symptomatic recurrent VTE, i.e., the composite of DVT, non-fatal PE, and fatal PE Time Frame: 12 months from time of randomization
- Secondary Outcome Measures
Name Time Method - The composite clinical outcome of symptomatic recurrent DVT, non-fatal symptomatic recurrent PE, and all-cause mortality - Clinically relevant bleeding (i.e., major or clinically relevant non-major bleeding) occurring during treatment
Trial Locations
- Locations (36)
Apollo speciality Hospitals,
🇮🇳Madurai, TAMIL NADU, India
Arneja Heart Institute
🇮🇳Nagpur, MAHARASHTRA, India
Banker's Heart Institute
🇮🇳Vadodara, GUJARAT, India
BD Mehta Mahavir Heart Institute,
🇮🇳Surat, GUJARAT, India
Bhagwan Mahaveer Jain Hospital
🇮🇳Bangalore, KARNATAKA, India
Center for Knee and Hip Surgery,
🇮🇳Vadodara, GUJARAT, India
Chennai Transplant Centre
🇮🇳Chennai, TAMIL NADU, India
Ciigma Institute of Medical Sciences Pvt Ltd
🇮🇳Aurangabad, MAHARASHTRA, India
Columbia Asia Referral Hospital
🇮🇳Bangalore, KARNATAKA, India
Convenient Hospitals Ltd.
🇮🇳Indore, MADHYA PRADESH, India
Scroll for more (26 remaining)Apollo speciality Hospitals,🇮🇳Madurai, TAMIL NADU, IndiaDr. Narayanasamy DurairajPrincipal investigatorscrcmdu@yahoo.co.in