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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00571649




Registration number
NCT00571649
Ethics application status
Date submitted
11/12/2007
Date registered
12/12/2007
Date last updated
15/09/2016

Titles & IDs
Public title
Venous Thromboembolic Event (VTE) Prophylaxis in Medically Ill Patients
Scientific title
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
Secondary ID [1] 0 0
2007-004614-14
Secondary ID [2] 0 0
12839
Universal Trial Number (UTN)
Trial acronym
MAGELLAN
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rivaroxaban (Xarelto, BAY59-7939)
Treatment: Drugs - Enoxaparin
Treatment: Drugs - Rivaroxaban placebo
Treatment: Drugs - Enoxaparin placebo

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

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


Treatment: Drugs: Rivaroxaban (Xarelto, BAY59-7939)
Oral rivaroxaban 10 mg once daily administered for 35 +/- 4 days

Treatment: Drugs: Enoxaparin
Subcutaneous enoxaparin 40 mg once daily (OD) administered for 10 +/- 4 days

Treatment: Drugs: Rivaroxaban placebo
Oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days

Treatment: Drugs: Enoxaparin placebo
Subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to Day 35 + 6 days
Primary outcome [2] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and VTE-related Death up to Day 10 + 5 Days
Timepoint [2] 0 0
Up to Day 10 + 5 days
Secondary outcome [1] 0 0
Percentage of Participants With Composite Endpoint of VTE (Any DVT, Non Fatal PE) and All-cause Mortality up to Day 35 + 6 Days
Timepoint [1] 0 0
Up to Day 35 + 6 days
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Up to Day 10 + 5 days
Secondary outcome [3] 0 0
Percentage of Participants With VTE Combined With All-cause Mortality up to Day 10 + 5 Days
Timepoint [3] 0 0
Up to Day 10 + 5 days
Secondary outcome [4] 0 0
Percentage of Participants With Symptomatic VTE, Including and Excluding VTE-related Death up to Days 10, 35, and 90
Timepoint [4] 0 0
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
Up to Day 35 + 6 days
Secondary outcome [6] 0 0
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
Timepoint [6] 0 0
Up to Day 10 + 5 days
Secondary outcome [7] 0 0
Percentage of Participants With Major Vascular Events up to Days 10, 35, and 90
Timepoint [7] 0 0
At Day 10 + 5 days, at Day 35 + 6 days, and at Day 90 + 7 days
Secondary outcome [8] 0 0
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
Timepoint [8] 0 0
Up to Day 35 + 6 days
Secondary outcome [9] 0 0
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
Timepoint [9] 0 0
Up to Day 10 + 5 days
Secondary outcome [10] 0 0
Percentage of Participants With All-cause Mortality up to Day 90 + 7 Days
Timepoint [10] 0 0
Up to Day 90 + 7 days
Secondary outcome [11] 0 0
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)
Timepoint [11] 0 0
Up to Day 35 + 6 days
Secondary outcome [12] 0 0
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)
Timepoint [12] 0 0
Up to Day 10 + 5 days

Eligibility
Key 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/11/2010
Sample size
Target
Accrual to date
Final
8101
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Garran
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- Kogarah
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- Lismore
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- Sydney
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- Auchenflower
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- Brisbane
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- Redcliffe
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- Southport
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- Woollongabba
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- Adelaide
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- Launceston
Recruitment hospital [12] 0 0
- Box Hill
Recruitment hospital [13] 0 0
- Clayton
Recruitment hospital [14] 0 0
- Melbourne
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- Perth
Recruitment postcode(s) [1] 0 0
2605 - Garran
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2217 - Kogarah
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2480 - Lismore
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2229 - Sydney
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4066 - Auchenflower
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4066 - Brisbane
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4101 - Brisbane
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4020 - Redcliffe
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4215 - Southport
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4102 - Woollongabba
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5042 - Adelaide
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7250 - Launceston
Recruitment postcode(s) [13] 0 0
3128 - Box Hill
Recruitment postcode(s) [14] 0 0
3168 - Clayton
Recruitment postcode(s) [15] 0 0
3135 - Melbourne
Recruitment postcode(s) [16] 0 0
3144 - Melbourne
Recruitment postcode(s) [17] 0 0
6000 - Perth
Recruitment outside Australia
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Bogota
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Gyor
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Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bayer
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00571649
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00571649