Deep vein thrombosis future or investigational therapies

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

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[1] ttp://clinicaltrials.gov/ct2/show/NCT01583218?term=APEX&rank=2

[2] ttps://clinicaltrials.gov/ct2/show/NCT02111564?term=MARINER&rank=1

[3] ttp://clinicaltrials.gov/ct2/show/NCT00633893

[4] ttp://clinicaltrials.gov/ct2/show/NCT00740493?term=deep+vein+thrombosis&rank=16

[5] ttp://clinicaltrials.gov/ct2/show/NCT01325779?term=deep+vein+thrombosis&rank=17

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Deep vein thrombosis future or investigational therapies

Overview

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]

A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients (MARINER)[2]

Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer [3]

Prolonged Anticoagulation After a First Episode of Idiopathic Proximal Deep Vein Thrombosis (PADIS TVP): Sponsored by University Hospital, Brest[4]

Comparison of Subcutaneous Heparin and Enoxaparin for DVT Prophylaxis in Surgical Intensive Care Patients: Sponsored by William Beaumont Hospitals[5]