Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients (MAGELLAN)
Venous Thromboembolism
About this trial
This is an interventional prevention trial for Venous Thromboembolism focused on measuring Acute medical illnesses with increased risk for VTE., Deep vein thrombosis (DVT), Pulmonary embolism (PE),, Venous Thromboembolic disease (VTE),, Medical illness
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
Sites / Locations
- Office of Dr. John Simmons, MD
- Hospital de Agudos "Dr. Carlos Bocalandro"
- Hospital Británico
- Sanatorio Mitre
- Hotel Dieu-Grace Hospital
- CHUM - Hopital Notre-Dame
- The 1st Affiliated Hosp of the 4th Military Med Uni
- 1st Affiliated Hosp., Med College Xi'an Jiaotong Univ.
- Beijing Friendship Hosp.
- National Hospital Organization Ibaraki Higashi Hospital
- Seoul National University Hospital
- Seoul Metropolitan Boramae Hospital
- Changi General Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Rivaroxaban (Xarelto, BAY59-7939)
Enoxaparin
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
Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days