Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients (MAGELLAN)

Bayer

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: Rivaroxaban placebo; Drug: Enoxaparin placebo; Drug: Enoxaparin; Drug: Rivaroxaban (Xarelto, BAY59-7939)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00571649

2007-004614-14 (EudraCT Number)

12839

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8,101 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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8,101 participants in 2 patient groups

Rivaroxaban (Xarelto, BAY59-7939)

Experimental group

Description:

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

Treatment:

Drug: Enoxaparin placebo

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Enoxaparin

Active Comparator group

Description:

Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days

Treatment:

Drug: Rivaroxaban placebo

Drug: Enoxaparin