A safety and Efficacy Trial Evaluating the Use of Apixaban in theTreatment of Symptomatic Deep Vein Thrombosis and PulmonaryEmbolism.

• Conditions: Venous Thromboembolism (VTE); MedDRA version: 14.1Level: PTClassification code 10051055Term: Deep vein thrombosisSystem Organ Class: 10047065 - Vascular disorders; MedDRA version: 14.1Level: PTClassification code 10037377Term: Pulmonary embolismSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2007-007867-25-AT
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07-01
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4816

Inclusion Criteria

a)Subjects whose index event was either unprovoked OR provoked with a risk for recurrence as described in the eligibility checklist.
b) Acute symptomatic proximal DVT with evidence of proximal thrombosis that involves at least the popliteal vein or a more proximal vein, demonstrated by imaging with:
- compression ultrasound (CUS), including grey-scale or color-coded Doppler,
or
- ascending contrast venography.
Or
c) Acute symptomatic PE with evidence of thrombosis demonstrated by imaging as follows:
- an intraluminal filling defect in segmental or more proximal branches on spiral CT scan; or
- an intraluminal filling defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram; or
- a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS).
d) Men and women, ages 18 years or greater.
Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Sex and Reproductive Status
a) WOCBP who are unwilling or unable to use an acceptable method of
birth control [such as oral contraceptives, other hormonal contraceptives
(vaginal products, skin patches, or implanted or injectable products), or
mechanical products such as an intrauterine device or barrier methods
(diaphragm, condoms, spermicides)] to avoid pregnancy for the entire
study.
b) Women who are pregnant or breastfeeding.
c) Women with a positive pregnancy test on enrollment or prior to
investigational product administration.

2) Target Disease Exceptions
a) Subjects with a provoked index event without the existence of a
persistent risk factor for recurrence as described in the eligibility
checklist.
b) Less than 6 months of anticoagulation planned for the most recent
DVT or PE (index event).
c) Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent
to treat the current episode of VTE.
d) Active bleeding or high risk for bleeding contraindicating treatment
with LMWH and a VKA.
e) Subjects with cancer who will be treated for 6-months or more with
low molecular weight heparin therapy.
f) Subjects with contraindications according to the local prescribing
information of enoxaparin or warfarin.

3) Medical History and Concurrent Diseases
a) Subjects with an indication, other than VTE, intended for long-term
treatment with a VKA such as:
- Mechanical valve
- Atrial fibrillation or atrial flutter with moderate to high risk of systemic
thromboembolism. Subjects with atrial fibrillation that appears to be
associated with acute PE may participate.
c) Active and clinically significant liver disease (eg, hepatorenal
syndrome);
d) Life expectancy < 6 months;
e) Bacterial endocarditis;
f) Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or
diastolic blood pressure > 100 mm Hg; (subjects who have a transient,
higher blood pressure elevation associated with acute PE [upper limit:
systolic blood pressure 200 mm Hg or diastolic blood pressure 100 mm
Hg] may enter the study;) elevated blood pressure that is persistent 1 -
2 days after the index DVT or PE should be treated according to local
guidelines);

4) Physical and Laboratory Test Findings
a) Platelet count < 100,000/mm3
b) Hemoglobin < 9 g/dL;
c) Serum creatinine > 2.5 mg/dL [221 umol/L]
d) Calculated creatinine clearance < 25 ml/min; (see Section 6.3.2.2.);
e) ALT or AST > 2 times upper limit of normal,
f) Total bilirubin > 1.5 times upper limit of normal (unless an alternative
causative factor is identified [eg, Gilbert's syndrome]).

5) Allergies and Adverse Drug Reactions
a) Heparin induced thrombocytopenia;
b) Allergic reaction to unfractionated heparin, LMWH, fondaparinux or
any VKA.

6) Prohibited Treatments and/or Therapies
a) DVT or PE treatment with more than two doses of fondaparinux or a
LMWH that is labeled for once daily dosing, or more than three doses of
a LMWH that is labeled for twice daily dosing, or continuous infusion of
unfractionated heparin for more than 36 hours, before the first
administration of study drug; and/or
b) DVT or PE treatment with more than two doses of oral VKA therapy
before the first administration of study drug.
c) Treatment with apixaban in a previous clinical trial.
d) Subjects requiring ASA > 165 mg/day at randomization.
e) Subjects requiring dual anti-platelet therapy (ASA plus clopidogrel or
ASA plus ticlopidine) at randomization. Subjects

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified