To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days reduces the rate of total venous thromboembolism (VTE) and VTE-related death compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a recommended…
ID
Source
Brief title
Condition
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite of total VTE and VTE-related death during 30 days of double-blind
treatment, where total VTE is defined as the combination of symptomatic deep
vein thrombosis, fatal or nonfatal symptomatic pulmonary embolism and
asymptomatic proximal deep vein thrombosis detected by compression ultrasound.
Secondary outcome
*Composite of total VTE, as defined above and VTE-related death occurring up to
the time of discontinuation of parenteral therapy.
*Composite of total VTE, as defined above and all-cause death at Day 30.
*Adjudicated major bleeding events during 30 days of double-blind treatment.
*Composite of adjudicated major and clinically relevant non-major bleeding
events during 30 days of double-blind treatment.
Background summary
A majority of hospitalized patients have risk factors for DVT and pulmonary
embolism. Hospitalisation for medical illness is associated with an 8-fold
increased relative risk for VTE.
In the absence of profylaxis the prevalence of VTE is estimated to be 10-20% in
medical patients.
Therefore VTE profylaxis is a valuable treatment.
However the treatment is often not optimally effective due to failure to
administer a dose, not optimal dosage or failure to continue prophylaxis
throughout the period of elevated risk. Prophylaxis would benefit from from the
availability of an agent that is safe and effective after oral administration.
Study objective
To demonstrate that oral administration of apixaban 2.5 mg BID for 30 days
reduces the rate of total venous thromboembolism (VTE) and VTE-related death
compared to standard, subcutaneous administration of enoxaparin 40 mg QD for a
recommended minimum period of 6 days, in subjects with acute medical illness.
Study design
Randomized, double-blind, double-dummy, 2-arm, multi-center trial
Intervention
One arm recieves oral apixaban 2.5 mg BID and once daily 40 mg subcutaneous
placebo fluid.
The other arm receives once daily subcutaneous enoxaparin 40 mg during
hospitalization and oral placebo tablets 2.5 mg BID.
Study burden and risks
The study will last for 90 days with a total of 6 visits taking 30 to 60
minutes. The patient will undergo the following procedures:
1 x complete physical examination
5 x abbreviated physical examination
6 x vital signs
2 x bilateral compression ultrasound
2 x ECG
4 x mobility questionnaire
6 x venapunction (12 ml each time)
For WOCBP a pregnancy test (urine) is required (4 times)
The possible side effects for apixaban are:
Increased risk for bleeding, nausea, obstipation, fever, vomitting, oedema,
arthralgia, sleeplessness, dizziness, erythema, itching, headache, tiredness,
stomach pain.
185 Chausee de la Hulpe
1170 Brussel
Belgie
185 Chausee de la Hulpe
1170 Brussel
Belgie
Listed location countries
Age
Inclusion criteria
1) Hospitalized due to
- congestive heart failure
- acute respiratory failure
- infection (without septic shock)
- acute rheumatic disorder
- inflammatory bowel disease
2) Except for subjects with congestive heart failure or respiratory failure subjects must have one additional risk factor for VTE.
3) Expected hospitalisation 3 days or longer after randomisation
4) Severely or moderately restricted mobility
Exclusion criteria
1) Subjects who received more than 2 days of prophylaxis for VTE
2) Subjects with surgery in the past 30 days
3) Subjects with a condition that requires chronic anticoagulation
4) Subjects with active bleeding or at high risk of bleeding
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-003674-96-NL |
| ClinicalTrials.gov | NCT00457002 |
| CCMO | NL17540.091.07 |