Deep vein thrombosis future or investigational therapies
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Assistant Editor(s)-In-Chief: Justine Cadet
Overview
There are several ongoing studies on future therapies for the prevention of venous thromboembolism (VTE). The APEX study is a multicenter, randomized, active-controlled efficacy and safety study comparing extended duration betrixaban with standard of care enoxaparin for the prevention of VTE in acute medically ill patients.[2] MARINER is a randomized, double-blind, placebo-controlled, event-driven, multicenter study in patients who are hospitalized for a specific acute medical illness and have other risk factors for VTE, which aims to evaluate rivaroxaban in the prevention of symptomatic VTE events and VTE-related deaths for a period of 45 days post-hospital discharge.[3]
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 |
A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients (MARINER)[2]
- Status: Currently recruiting
- Primary Outcome Measures: Occurrence of symptomatic venous thromboembolism event (VTE) and VTE-related death
- Estimated Enrollment: 8000
- Study Start Date: June 2014
- Estimated Study Completion Date: February 2017
| Arms | Assigned Content |
| Experimental: Rivaroxaban | Drug: Drug: Rivaroxaban, 10 mg - Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening >= 50 mL/min will receive 10 mg rivaroxaban tablet with or without food. Drug: Rivaroxaban, 7.5 mg- Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from 30 to 49 mL/min will receive 7.5 mg rivaroxaban tablet with or without food. |
| Placebo Comparator: Placebo | Drug: Placebo |
Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer [3]
- 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 Episode of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP): Sponsored by University Hospital, Brest[4]
- 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[5]
- 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
- ↑ http://clinicaltrials.gov/ct2/show/NCT01583218?term=APEX&rank=2
- ↑ https://clinicaltrials.gov/ct2/show/NCT02111564?term=MARINER&rank=1
- ↑ http://clinicaltrials.gov/ct2/show/NCT00633893
- ↑ http://clinicaltrials.gov/ct2/show/NCT00740493?term=deep+vein+thrombosis&rank=16
- ↑ http://clinicaltrials.gov/ct2/show/NCT01325779?term=deep+vein+thrombosis&rank=17