Phase 3
N=8,101
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Venous Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00571649 ↗Enrolled (actual)
8,101
Serious AEs
25.1%
Results posted
Jun 2012
Primary outcome: Primary: Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days — 4.4; 5.7 Percentage of participants — p=0.0211
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rivaroxaban (Xarelto, BAY59-7939) (Drug); Enoxaparin (Drug); Rivaroxaban placebo (Drug); Enoxaparin placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Bayer
- Primary completion
- Aug 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Composite Endpoint of Venous Thromboembolism [VTE] (Any Deep Vein Thrombosis [DVT], Non Fatal Pulmonary Embolism [PE]) and VTE-related Death up to Day 35 + 6 Days |
4.4; 5.7 | 0.0211 sig |
| PRIMARY Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days |
2.7; 2.7 | 0.0025 sig |
| SECONDARY Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days |
8.6; 9.2 | 0.3758 |
| SECONDARY Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Per mITT Population |
3.0; 3.1 | 0.9473 |
| SECONDARY Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days |
4.8; 4.5 | — |
| SECONDARY Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90 |
0.7; 0.6; 0.5; 0.3; 1.0; 1.4 | — |
| SECONDARY Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 35 + 6 Days |
9.4; 7.8 | — |
| SECONDARY Percentage of Participants With Net Clinical Benefit (Any DVT, Non-fatal PE, VTE-related Death, Plus Major and Clinically Relevant Non-major Bleeding Events) up to Day 10 + 5 Days |
4.5; 3.9 | — |
| SECONDARY Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90 |
1.0; 1.0; 0.3; 0.3; 0.5; 0.4 | — |
| SECONDARY Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 35 + 6 Days |
0.3; 0.5; 0.4; 0.5; 3.5; 4.4 | — |
| SECONDARY Percentage of Participants With Each Component of the Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days |
0.2; 0.1; 0.2; 0.2; 2.4; 2.4 | — |
| SECONDARY Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days |
6.7; 6.2; 1.4; 1.4; 4.3; 3.7 | — |
| SECONDARY Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Intake of Any Study Medication (Day 35 + 6 Days) |
4.1; 1.7 | <0.0001 sig |
| SECONDARY Percentage of Participants With the Composite of Treatment Emergent Major Bleeding Events and Non-major Clinically Relevant Bleeding Events up to 2 Days After Last Application of a Study Medication Syringe (Day 10 + 5 Days) |
2.8; 1.2 | <0.0001 sig |
Summary
This study will evaluate if extended therapy with oral rivaroxaban can prevent blood clots in the leg and lung that can occur with patients hospitalized for acute medical illness, and compare these results with those of the standard enoxaparin dose and duration regimen. The safety of rivaroxaban will also be studied.
Eligibility Criteria
Inclusion Criteria
- Male and female patients aged 40 years or more
- Patients at risk of venous thromboembolic events being hospitalized for acute medical conditions as follows:
- Heart failure, New York Heart Association (NYHA) class III or IV
- Active cancer
- Acute ischemic stroke
- Acute infectious and inflammatory diseases, including acute rheumatic diseases
- Acute respiratory insufficiency
- Additional risk factor for VTE, including reduced mobility
Exclusion Criteria
- Conditions that contraindicate the use of antithrombotic therapy with the Low Molecular-Weight Heparin (LMWH) enoxaparin
- Conditions that may increase the risk of bleeding, including intracranial hemorrhage
- Required drugs or procedures which may interfere with the study treatment
- Concomitant conditions or diseases which may increase the risk of study subjects or interfere with the study outcome
- General conditions in which subjects are not suitable to participate in the study
Data sourced from ClinicalTrials.gov (NCT00571649). 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.