Deep vein thrombosis future or investigational therapies: Difference between revisions

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====Comparison of Subcutaneous Heparin and Enoxaparin for DVT Prophylaxis in Surgical Intensive Care Patients: Sponsored by William Beaumont Hospitals<ref>http://clinicaltrials.gov/ct2/show/NCT01325779?term=deep+vein+thrombosis&rank=17</ref>====
====Comparison of Subcutaneous Heparin and Enoxaparin for DVT Prophylaxis in Surgical Intensive Care Patients: Sponsored by William Beaumont Hospitals<ref>http://clinicaltrials.gov/ct2/show/NCT01325779?term=deep+vein+thrombosis&rank=17</ref>====

Revision as of 02:54, 20 June 2012

Ongoing Research

Phase 3 Trials

Acute Medically Ill venous thromboembolism (VTE) Prevention With Extended Duration Betrixaban Study (The APEX Study): Sponsored by Portola Pharmaceuticals[1]

  • Primary Outcome Measures: Composite of VTE (Deep Vein Thrombosis (DVT) and/or Pulmonary Embolism (PE)) and VTE death
  • Secondary Outcome Measures: Number of patients with symptomatic VTE
  • Estimated Enrollment: 6,850 patients
  • Study Start Date: March 2012
  • Estimated Study Completion Date: December 2014
Arms Assigned Content
Experimental: Betrixaban Drug: Betrixaban: Betrixaban 80 mg PO QD for 35 day + seven days/Enoxaparin Placebo: Once daily, 6-14 days
Active Comparator: Enoxaparin Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 ± four days/Betrixaban Placebo: once daily, 35 days

Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer [2]

  • Status: Currently recruiting
  • Primary Outcome Measures: Venous Thromboembolic Recurrence or Death
  • Secondary Outcome Measures: Bleeding
  • Estimated Enrollment: 2,430 patients
  • Study Start Date: May 2008
  • Estimated Study Completion Date: August 2012
Arms Assigned Content
Experimental: 1 - 2.5 mg Drug: Apixaban - Tablets, Oral, twice daily, 12 months (Other Name: BMS-562247)
Experimental: 2 - 5 mg Drug: Apixaban - Tablets, Oral, twice daily, 12 months (Other Name: BMS-562247)
Active Comparator: 3 Drug: Drug: Placebo - Tablets, Oral, twice daily, 12 months

Prolonged Anticoagulation After a First Episod of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP): Sponsored by University Hospital, Brest[3]

  • Status: Currently recruiting
  • Primary Outcome Measures: Symptomatic recurrent VTE and serious bleeding
  • Secondary Outcome Measures: Mortality due to another cause than recurrent VTE or serious bleeding
  • Estimated Enrollment: 374 patients
  • Study Start Date: July 2007
  • Estimated Study Completion Date: November 2013
Arms Assigned Content
Active Comparator: 1 - 18 months of active warfarin therapy Drug: Warfarin - 18 months of warfarin therapy
Placebo Comparator: 2 - 18 months of placebo of warfarin Drug: Placebo of warfarin - 18 months of placebo of warfarin therapy

Comparison of Subcutaneous Heparin and Enoxaparin for DVT Prophylaxis in Surgical Intensive Care Patients: Sponsored by William Beaumont Hospitals[4]

  • Status: Currently recruiting
  • Primary Outcome Measures: Development of lower extremity DVT
  • Secondary Outcome Measures: Adverse events associated with use of subcutaneous heparin and enoxaparin
  • Estimated Enrollment: 400 patients
  • Study Start Date: March 2011
  • Estimated Study Completion Date: December 2014
Arms Assigned Content
Active Comparator: Subcutaneous heparin Drug: Heparin - subcutaneous heparin 5000 units every eight hours
Active Comparator: Subcutaneous enoxaparin Drug: Enoxaparin - subcutaneous enoxaparin 40 milligrams every 24 hours

References


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