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

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ClinicalTrials.gov Identifier: NCT00571649
Recruitment Status : Completed
First Posted : December 12, 2007
Results First Posted : June 27, 2012
Last Update Posted : September 15, 2016
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date  ICMJE December 11, 2007
First Posted Date  ICMJE December 12, 2007
Results First Submitted Date February 16, 2012
Results First Posted Date June 27, 2012
Last Update Posted Date September 15, 2016
Study Start Date  ICMJE December 2007
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
  • 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 ]
    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 ]
    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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Composite of VTE (DVT and/or PE) and Death [ Time Frame: +/- 4 days ]
Change History Complete list of historical versions of study NCT00571649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 24, 2012)
  • 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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2007)
Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: +/- 4 days ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Venous Thromboembolism
Intervention  ICMJE
  • 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
Study Arms
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 13, 2011)
8101
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2007)
8000
Actual Study Completion Date November 2010
Actual Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   Chile,   China,   Colombia,   Croatia,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   India,   Indonesia,   Israel,   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,   United Kingdom,   United States
Removed Location Countries Ireland
 
Administrative Information
NCT Number  ICMJE NCT00571649
Other Study ID Numbers  ICMJE 12839
2007-004614-14 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date August 2016

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