Deep vein thrombosis future or investigational therapies: Difference between revisions
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===Phase 3 Trials (of New Treatment Options)=== | ===Phase 3 Trials (of New Treatment Options)=== | ||
====Acute Medically Ill | ====Acute Medically Ill venous thromboembolism (VTE) Prevention With Extended Duration Betrixaban Study (The APEX Study): Sponsored by Portola Pharmaceuticals<ref>http://clinicaltrials.gov/ct2/show/NCT01583218?term=APEX&rank=2</ref>==== | ||
* Status: Currently recruiting | * Status: Currently recruiting | ||
* Primary Outcome Measures: Composite of VTE ([[deep vein thrombosis]] (DVT) and/or [[pulmonary embolism]] (PE)) and VTE death | * Primary Outcome Measures: Composite of VTE ([[deep vein thrombosis]] (DVT) and/or [[pulmonary embolism]] (PE)) and VTE death | ||
Revision as of 17:01, 31 January 2013
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Assistant Editor(s)-In-Chief: Justine Cadet
Future or Investigational Therapies
Phase 3 Trials (of New Treatment Options)
Acute Medically Ill venous thromboembolism (VTE) Prevention With Extended Duration Betrixaban Study (The APEX Study): Sponsored by Portola Pharmaceuticals[1]
- Status: Currently recruiting
- 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 |