Phase 3
Completed N=7,513
Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Venous Thromboembolism (VTE)
Source: ClinicalTrials.gov NCT01583218 ↗
Enrolled (actual)
7,513
Serious AEs
17.1%
Results posted
Sep 2017
Primary outcomePrimary: 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 — 5.70; 7.18 Percentage of Participants — p=0.038
◆ Published Evidence
Established
21citations · ~3 / year
Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy.
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.
Linked Publications (5)
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Extended-duration betrixaban versus shorter-duration enoxaparin for venous thromboembolism prophylaxis in critically ill medical patients: an APEX trial substudy.
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External validation of the ADA score for predicting thrombosis among acutely ill hospitalized medical patients from the APEX Trial.
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Extended Thromboprophylaxis With Betrixaban or Rivaroxaban for Acutely Ill Hospitalized Medical Patients: Meta-Analysis of Prespecified Subgroups.
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Characterization of Major and Clinically Relevant Non-Major Bleeds in the APEX Trial.
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Budget impact analysis of betrixaban for venous thromboembolism prophylaxis in nonsurgical patients with acute medical illness in the United Kingdom.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
5.70; 7.18 | 0.038 sig |
| 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 |
4.70; 6.02 | 0.018 sig |
| 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 |
4.43; 5.99 | 0.003 sig |
| PRIMARY Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication |
0.67; 0.57 | 0.554 |
| SECONDARY mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 |
1.30; 1.90 | 0.092 |
| SECONDARY mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 |
1.03; 1.45 | 0.11 |
| SECONDARY mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3 |
0.94; 1.45 | 0.039 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01583218) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.