Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

Portola Pharmaceuticals7,513 enrolled

Overview

The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for an acute medical illness and to compare these results with standard of care enoxaparin. The safety of betrixaban will also be studied.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

7,513

Conditions

Venous Thromboembolism (VTE)

Interventions

BetrixabanDRUG

Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days

EnoxaparinDRUG

Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days. Betrixaban Placebo: once daily, 35 days

Eligibility

Sex: ALLMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * men and non-pregnant, non-breastfeeding women * anticipated to be severely immobilized for at least 24 hours after randomization * hospitalized with one of the following * congestive heart failure * acute respiratory failure, * acute infection without septic shock, * acute rheumatic disorders * acute ischemic stroke with lower extremity hemiparesis or hemi paralysis Exclusion Criteria: * a condition requiring prolonged anticoagulation or anti-platelets * active bleeding or at high risk of bleeding * contraindication to anticoagulant therapy * general conditions in which subjects are not suitable to participate in the study

Locations (462)

Outcomes

Primary Outcomes

Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3

mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, venous thromboembolism (VTE) related death adjudicated by a blinded independent Clinical Events Committee (CEC) between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).

Time frame: mITT Cohort 1: Between randomization and Day 47 (max)

mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3

mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).

Time frame: mITT Cohort 2: Between randomization and Day 47 (max)

mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3

mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3, or a blinded ultrasound core laboratory measuring of asymptomatic proximal DVT between randomization and Day 47. Visit 3 is between day 35-42 after randomization (day 1).

Time frame: mITT: Between randomization and Day 47 (max)

Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication

Data from ClinicalTrials.gov

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Unnamed facility

Birmingham, Alabama, United States

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Bakersfield, California, United States

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Fresno, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Modesto, California, United States

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San Diego, California, United States

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Stanford, California, United States

Unnamed facility

Torrance, California, United States

...and 452 more locations

Secondary Outcomes

mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3

mITT Cohort 1: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).

Time frame: mITT Cohort 1: Between randomization and Day 42 (max)

mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3

mITT Cohort 2: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).

Time frame: mITT Cohort 2: Between randomization and Day 42 (max)

mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3

mITT: Percentage of participants experiencing either symptomatic DVT, non-fatal PE, or VTE related death adjudicated by a blinded independent CEC between randomization and on or before Visit 3 or Day 42 if patient did not have a Visit 3. Visit 3 is between day 35-42 after randomization (day 1).

Time frame: mITT: Between randomization and Day 42 (max)