Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients


Tracking Information

Start Date  ICMJEDecember 2007
Estimated Primary Completion DateJuly 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: June 30, 2008)		Composite of VTE (DVT and/or PE) and Death [ Time Frame: up to day 35 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: December 11, 2007)		Composite of VTE (DVT and/or PE) and Death [ Time Frame: +/- 4 days ]
Change HistoryComplete list of historical versions of study NCT00571649 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: December 21, 2007)		Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: 90 + 7 days ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: December 11, 2007)		Individual components of the composite endpoint and other cardiovascular events. [ Time Frame: +/- 4 days ]

Descriptive Information

Brief Title  ICMJEVenous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Official Title  ICMJEMAGELLAN - Multicenter, Randomized, Parallel Group Efficacy and Safety Study for the Prevention of Venous Thromboembolism in Hospitalized Medically Ill Patients Comparing Rivaroxaban With Enoxaparin
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

Within the US 'Johnson & Johnson Pharmaceutical Research & Development, L.L.C.' is sponsor.

Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJEVenous Thromboembolism
Intervention  ICMJE
  • Drug: Xarelto (Rivaroxaban, 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
Study Arms / Comparison Groups
  • Arm 1: Experimental
    Intervention: Drug: Xarelto (Rivaroxaban, BAY59-7939)
  • Arm 2: Active Comparator
    Intervention: Drug: Enoxaparin

Recruitment Information

Estimated Enrollment  ICMJE8000
Estimated Completion DateJuly 2010
Estimated Primary Completion DateJuly 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, 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 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
GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Bayer Clinical Trials Contactclinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options '3' or '4')(+)1-888-84 22937
Location Countries  ICMJEUnited 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,   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

Administrative Information

NCT ID  ICMJENCT00571649
Responsible PartyTherapeutic Area Head, Bayer HealthCare AG
Study ID Numbers  ICMJE12839, MAGELLAN, EudraCT: 2007-004614-14
Study Sponsor  ICMJEBayer
Collaborators  ICMJEJohnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators  ICMJE
Study Director:Bayer Study DirectorBayer
Information Provided ByBayer