Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
- Conditions
- Venous Thromboembolism
- Interventions
- Registration Number
- NCT00571649
- Lead Sponsor
- Bayer
- Brief 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.
- Detailed Description
The treatment period was followed by a follow-up period starting the day after the last intake of study medication, regardless of the actual duration of study drug administration and ended on Day 90 (+ 7 days). Participants who did not complete the treatment period also entered the follow-up period. It was also possible that participants did not enter the follow-up period, e.g. due to withdrawal of consent or termination of study participation.
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8101
-
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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rivaroxaban (Xarelto, BAY59-7939) Rivaroxaban (Xarelto, BAY59-7939) Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days Rivaroxaban (Xarelto, BAY59-7939) Enoxaparin placebo Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days Enoxaparin Rivaroxaban placebo Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days Enoxaparin Enoxaparin Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
- Primary Outcome Measures
Name Time Method 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 Up to Day 35 + 6 days A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days Up to Day 10 + 5 days A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
- Secondary Outcome Measures
Name Time Method Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days Up to Day 35 + 6 days A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
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 Up to Day 10 + 5 days A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days Up to Day 10 + 5 days A composite endpoint of: asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and death (VTE-related and not VTE-related).
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90 At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days Symptomatic VTE (non-fatal PE and DVT in lower extremity), including and excluding VTE-related death (PE and PE cannot be excluded) up to Days 10, 35, and 90
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 Up to Day 35 + 6 days Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events.
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 Up to Day 10 + 5 days Net clinical benefit is a composite of the primary efficacy endpoint (asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death) plus major and clinically relevant non-major bleeding events
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90 At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days Major vascular events included cardiovascular death, acute myocardial infarction (MI), or acute ischemic stroke. Participants may have had a vascular event in more than one category.
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 Up to Day 35 + 6 days The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
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 Up to Day 10 + 5 days The components of the composite endpoint include asymptomatic proximal DVT in lower extremity detected by mandatory bilateral lower extremity venous ultrasonography; symptomatic DVT in lower extremity, proximal or distal; symptomatic, non-fatal PE; and VTE-related death.
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days Up to Day 90 + 7 days All deaths, including VTE-related deaths, cardiovascular deaths, and other deaths.
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) Up to Day 35 + 6 days Major bleeding events were defined as events leading to \>=2 g/dL fall in hemoglobin; or transfusion of \>= 2 units of packed RBCs (Red blood cells) or whole blood; or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding
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) Up to Day 10 + 5 days Major bleeding events were defined as events leading to \>=2 g/dL fall in hemoglobin or transfusion of \>=2 units of packed RBCs or whole blood or leading to death. Non-major bleeding events were defined as overt bleeding not meeting the criteria of major bleeding.
Trial Locations
- Locations (13)
Sanatorio Mitre
🇦🇷Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
CHUM - Hopital Notre-Dame
🇨🇦Montreal, Quebec, Canada
Hotel Dieu-Grace Hospital
🇨🇦Windsor, Ontario, Canada
Seoul Metropolitan Boramae Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of
1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.
🇨🇳Xi'an, Shaanxi, China
Changi General Hospital
🇸🇬Singapore, Singapore
National Hospital Organization Ibaraki Higashi Hospital
🇯🇵Ibaraki, Japan
Office of Dr. John Simmons, MD
🇺🇸Geneva, Alabama, United States
Hospital Británico
🇦🇷Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Hospital de Agudos "Dr. Carlos Bocalandro"
🇦🇷Tres de Febrero, Buenos Aires, Argentina
Beijing Friendship Hosp.
🇨🇳Beijing, China
The 1st Affiliated Hosp of the 4th Military Med Uni
🇨🇳Xi'an, Shaanxi, China
Seoul National University Hospital
🇰🇷Seoul, Seoul Teugbyeolsi, Korea, Republic of