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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00571649
First received: December 11, 2007
Last updated: June 3, 2014
Last verified: June 2014

December 11, 2007
June 3, 2014
December 2007
August 2010   (final data collection date for primary outcome measure)
  • 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 [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    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.
Composite of VTE (DVT and/or PE) and Death [ Time Frame: +/- 4 days ]
Complete list of historical versions of study NCT00571649 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Up to Day 90 + 7 days ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to Day 35 + 6 days ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Up to Day 10 + 5 days ] [ Designated as safety issue: Yes ]
    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.
Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: +/- 4 days ]
Not Provided
Not Provided
 
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Multicenter, Randomized, Parallel-group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin. The MAGELLAN Study

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Venous Thromboembolism
  • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days
  • Drug: Enoxaparin
    Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days
  • Drug: Rivaroxaban placebo
    Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days
  • Drug: Enoxaparin placebo
    Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
  • Experimental: 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
    Interventions:
    • Drug: Rivaroxaban (Xarelto, BAY59-7939)
    • Drug: Enoxaparin placebo
  • Active Comparator: Enoxaparin
    Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
    Interventions:
    • Drug: Enoxaparin
    • Drug: Rivaroxaban placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8101
November 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel,   United States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   United Kingdom,   Italy,   Japan,   Korea, Republic of,   Latvia,   Lithuania,   Luxembourg,   Malaysia,   Mexico,   Netherlands,   New Zealand,   Norway,   Pakistan,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Singapore,   Slovakia,   Slovenia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   Ukraine
 
NCT00571649
12839, 2007-004614-14
Yes
Bayer
Bayer
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Study Director: Bayer Study Director Bayer
Bayer
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP