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__NOTOC__
__NOTOC__
{| class="infobox" style="float:right;"
|-
| [[File:Siren.gif|30px|link=Pulmonary embolism resident survival guide]]|| <br> || <br>
| [[Pulmonary embolism resident survival guide|'''Resident'''<br>'''Survival'''<br>'''Guide''']]
|}
{{Pulmonary embolism}}
{{Pulmonary embolism}}
'''Editor(s)-In-Chief:''' {{ATI}}, [[C. Michael Gibson, M.S., M.D.]] [mailto:charlesmichaelgibson@gmail.com]; {{AE}} {{Rim}}
'''Editor(s)-In-Chief:''' {{ATI}}, [[C. Michael Gibson, M.S., M.D.]] [mailto:charlesmichaelgibson@gmail.com]; {{AE}} {{Rim}}
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==Overview==
==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.[http://clinicaltrials.gov/ct2/show/study/NCT01583218?term=APEX+and+betrixaban&rank=1]  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.[http://clinicaltrials.gov/ct2/show/study/NCT02111564?term=MARINER&rank=1]
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.[http://clinicaltrials.gov/ct2/show/study/NCT01583218?term=APEX+and+betrixaban&rank=1]  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.[http://clinicaltrials.gov/ct2/show/study/NCT02111564?term=MARINER&rank=1]
==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<ref>http://clinicaltrials.gov/ct2/show/NCT01583218?term=APEX&rank=2</ref>====
* 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
<table>
<tr>
<td>'''Arms'''</td>
<td>'''Assigned Content'''</td>
</tr>
<tr>
<td>Experimental: Betrixaban</td>
<td>Drug: Betrixaban: Betrixaban 80 mg PO QD for 35 day + seven days/Enoxaparin Placebo: Once daily, 6-14 days</td>
</tr>
<tr>
<td>Active Comparator: Enoxaparin</td>
<td>Drug: Enoxaparin: Enoxaparin 40 mg SC QD for 10 ± four days/Betrixaban Placebo: once daily, 35 days</td>
</tr>
</table>
====A Study of Rivaroxaban (JNJ-39039039) on the Venous Thromboembolic Risk in Post-Hospital Discharge Patients (MARINER)<ref>https://clinicaltrials.gov/ct2/show/NCT02111564?term=MARINER&rank=1</ref>====
* 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
<table>
<tr>
<td>'''Arms'''</td>
<td>'''Assigned Content'''</td>
</tr>
<tr>
<td>Experimental: Rivaroxaban</td>
<td>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.<br>
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.
</tr>
<tr>
<td>Placebo Comparator: Placebo</td>
<td>Drug: Placebo</td>
</tr>
</table>
====Efficacy and Safety Study of Apixaban for Extended Treatment of DVT or PE: Sponsored by Bristol-Myers Squibb and Pfizer <ref>http://clinicaltrials.gov/ct2/show/NCT00633893</ref>====
* 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<ref>http://clinicaltrials.gov/ct2/show/NCT00740493?term=deep+vein+thrombosis&rank=16</ref>====
* 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<ref>http://clinicaltrials.gov/ct2/show/NCT01325779?term=deep+vein+thrombosis&rank=17</ref>====
* 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==
==References==
{{Reflist|2}}
{{Reflist|2}}
{{WH}}
{{WS}}


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[[Category:Intensive care medicine]]
[[Category:Intensive care medicine]]
[[Category:Primary care]]
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Latest revision as of 23:53, 29 July 2020
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Editor(s)-In-Chief: The APEX Trial Investigators, C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rim Halaby, M.D. [2]

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.[3] 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.[4]

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

  1. ↑ http://clinicaltrials.gov/ct2/show/NCT01583218?term=APEX&rank=2
  2. ↑ https://clinicaltrials.gov/ct2/show/NCT02111564?term=MARINER&rank=1
  3. ↑ http://clinicaltrials.gov/ct2/show/NCT00633893
  4. ↑ http://clinicaltrials.gov/ct2/show/NCT00740493?term=deep+vein+thrombosis&rank=16
  5. ↑ http://clinicaltrials.gov/ct2/show/NCT01325779?term=deep+vein+thrombosis&rank=17

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