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

Venous Thromboembolism (VTE) Clinical Trial

— APEX  

Official title:

(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01583218
• Other study ID #: 11-019
• Status: Completed
• Phase: Phase 3
• Start date: March 2012
• Est. completion date: January 2016

Study information

• Verified date: August 2023
• Source: Alexion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7513
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism
• Venous Thromboembolism (VTE)

Intervention

Drug:
• Betrixaban
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days. Enoxaparin Placebo: Once daily, 6-14 days
• Enoxaparin
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days. Betrixaban Placebo: once daily, 35 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Portola Pharmaceuticals

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Georgia,  Germany,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Montserrat,  Peru,  Poland,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	mITT Cohort 1: Between randomization and Day 47 (max)
Primary	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).	mITT Cohort 2: Between randomization and Day 47 (max)
Primary	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).	mITT: Between randomization and Day 47 (max)
Primary	Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication	Percentage of participants experiencing at least one major bleeding adjudicated by a blinded independent CEC between randomization (day 1) and up to seven days after discontinuation of all study medication.	Between randomization and Day 49 (max)
Secondary	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).	mITT Cohort 1: Between randomization and Day 42 (max)
Secondary	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).	mITT Cohort 2: Between randomization and Day 42 (max)
Secondary	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).	mITT: Between randomization and Day 42 (max)