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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/NCT01583218




Registration number
NCT01583218
Ethics application status
Date submitted
16/04/2012
Date registered
23/04/2012
Date last updated
7/08/2023

Titles & IDs
Public title
Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)
Scientific title
(Apex) Multicenter, Randomized, Active-Controlled Efficacy And Safety Study Comparing Extended Duration Betrixaban With Standard Of Care Enoxaparin For The Prevention Of Venous Thromboembolism In Acute Medically Ill Patients
Secondary ID [1] 0 0
11-019
Universal Trial Number (UTN)
Trial acronym
APEX
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Venous Thromboembolism (VTE) 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 - Betrixaban
Treatment: Drugs - Enoxaparin

Experimental: Betrixaban - Daily oral (PO) betrixaban capsules for 35 to 42 days and subcutaneous (SQ) injections of enoxaparin placebo for 10 ± 4 days

Active Comparator: Enoxaparin - Daily subcutaneous (SQ) injections of enoxaparin for 10 ± 4 days and oral (PO) betrixaban placebo capsules for 35 to 42 days


Treatment: Drugs: Betrixaban
Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
Enoxaparin Placebo: Once daily, 6-14 days

Treatment: Drugs: Enoxaparin
Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
Betrixaban Placebo: once daily, 35 days
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Modified Intent-to-Treat (mITT) Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic Deep Vein Thrombosis (DVT), Non-fatal Pulmonary Emboli (PE), VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
Timepoint [1] 0 0
mITT Cohort 1: Between randomization and Day 47 (max)
Primary outcome [2] 0 0
mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
Timepoint [2] 0 0
mITT Cohort 2: Between randomization and Day 47 (max)
Primary outcome [3] 0 0
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, VTE-related Death, or Asymptomatic Proximal DVT, Through Visit 3
Timepoint [3] 0 0
mITT: Between randomization and Day 47 (max)
Primary outcome [4] 0 0
Percentage of Participants Experiencing Major Bleeding Through Seven Days After Discontinuation of All Study Medication
Timepoint [4] 0 0
Between randomization and Day 49 (max)
Secondary outcome [1] 0 0
mITT Cohort 1: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
Timepoint [1] 0 0
mITT Cohort 1: Between randomization and Day 42 (max)
Secondary outcome [2] 0 0
mITT Cohort 2: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
Timepoint [2] 0 0
mITT Cohort 2: Between randomization and Day 42 (max)
Secondary outcome [3] 0 0
mITT: Percentage of Participants Experiencing the Composite Event of Symptomatic DVT, Non-fatal PE, or VTE-related Death, Through Visit 3
Timepoint [3] 0 0
mITT: Between randomization and Day 42 (max)

Eligibility
Key inclusion criteria
- men and non-pregnant, non-breastfeeding women

- anticipated to be severely immobilized for at least 24 hours after randomization

- hospitalized with one of the following

- congestive heart failure

- acute respiratory failure,

- acute infection without septic shock,

- acute rheumatic disorders

- acute ischemic stroke with lower extremity hemiparesis or hemi paralysis
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- a condition requiring prolonged anticoagulation or anti-platelets

- active bleeding or at high risk of bleeding

- contraindication to anticoagulant therapy

- 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
1/03/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
7513
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Recruitment hospital [1] 0 0
- Redcliffe
Recruitment hospital [2] 0 0
- Bedford Park
Recruitment hospital [3] 0 0
- Nedlands
Recruitment hospital [4] 0 0
- Milton
Recruitment hospital [5] 0 0
- Parkville
Recruitment hospital [6] 0 0
- Randwick
Recruitment hospital [7] 0 0
- Richmond
Recruitment postcode(s) [1] 0 0
4020 - Redcliffe
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment postcode(s) [4] 0 0
Qld 4064 - Milton
Recruitment postcode(s) [5] 0 0
Vic 3050 - Parkville
Recruitment postcode(s) [6] 0 0
- Randwick
Recruitment postcode(s) [7] 0 0
Vic 3121 - Richmond
Recruitment outside Australia
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Coronel Suarez, Buenos Aires
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São José Do Rio Preto- SP
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Sandanski
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Sliven
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Mohács
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Nagykanizsa
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Szolnok
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Veszprém
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Hungary
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Israel
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Kfar Saba
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Israel
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Petach Tikva
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Israel
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Tel Aviv
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Israel
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Zerifin
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Treviso
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Bollate
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Frenze
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Italy
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Genova
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Milano
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Napoli
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Italy
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Parma
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Pavia
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Piacenza
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Italy
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Reggio Emilia
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Italy
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Roma
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Italy
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Varese
Country [217] 0 0
Italy
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Venezia
Country [218] 0 0
Italy
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Vittorio Veneto TV
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Latvia
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Daugavpils
Country [220] 0 0
Latvia
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Liepaja
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Latvia
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Riga
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Latvia
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Southall

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Portola Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to evaluate whether extended prophylaxis with oral betrixaban
can prevent blood clots in the leg and lung that sometime occur in patients hospitalized for
an acute medical illness and to compare these results with standard of care enoxaparin. The
safety of betrixaban will also be studied.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01583218
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT01583218