A SAFETY AND EFFICACY TRIAL EVALUATING THE USE OF APIXABAN FOR THE EXTENDED TREATMENT OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM. - ND
- Conditions
- Venous Thrombombolism (VTE)MedDRA version: 9.1Level: LLTClassification code 10037377Term: Pulmonary embolismMedDRA version: 9.1Level: LLTClassification code 10051055Term: Deep vein thrombosis
- Registration Number
- EUCTR2007-004953-27-IT
- Lead Sponsor
- BRISTOL-M.SQUIBB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2430
1) Signed Written Informed Consent a) Subjects must be willing and able to give written informed consent. 2) Target Population a) Subjects who have: an objectively documented index event of symptomatic proximal DVT or symptomatic PE; (1) Symptomatic proximal DVT is defined as symptomatic DVT with evidence of thrombosis in a deep vein proximal to (above) the popliteal vein, demonstrated by imaging with compression ultrasound (CUS), including grey-scale or color-coded Doppler, or ascending contrast venography. (2) 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) completed approximately 6 to 12 months of standard anticoagulant therapy for the treatment of the index event; and no objectively documented symptomatic recurrence of VTE after the index event. b) Subjects should be randomized within approximately 7 days of the last dose of their initial 6-to 12-month treatment or when their INR is 2 or less, if a VKA was used. Every attempt should be made to randomize subjects as soon as possible after discontinuation of their initial treatment. The index DVT and/or PE will be adjudicated by the ICAC according to the adjudication manual. Investigators are encouraged to assemble and to submit imaging dossiers to the ICAC as soon as possible during the period that extends from the beginning of the screening period up to 2 weeks after randomization. 3) Age and Sex a) 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
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) Medical History and Concurrent Diseases a) Subjects whose index and past DVT(s) and/or PE(s) have all been due solely to a transient (reversible) risk factor (ie, provoked event, eg, secondary to surgery), and who are not expected to have, for 12 months or longer after randomization,persistence of a risk factor (e.g., wheelchair-bound) for DVT and/or PE recurrence. b) More than 12 months of anticoagulation planned for the most recent DVT or PE(index event). c) Subjects with the following indications for long-term treatment with a VKA, such as: Mechanical valve Atrial fibrillation or atrial flutter with moderate to high risk of systemic thromboembolism Multiple episodes of unprovoked DVT or PE Documented anti-phospholipid antibodies, anti-thrombin III deficiency,protein C deficiency, protein S deficiency, homozygous factor V Leiden, or homozygous prothrombin gene mutation. d) Subjects with cancer who will be treated indefinitely with anticoagulation therapy; e) serius bleeding prior randomization (see table under protocol section 4.2.2 for exact timing of occurrence resulting in subject exclusion from the study); f) Active and clinically significant liver disease (eg, hepatorenal syndrome); g) Life expectancy < 12 months; h) Bacterial endocarditis; i) Uncontrolled hypertension: systolic blood pressure >180 mm Hg or diastolic blood pressure >100 mm Hg. 3) Physical and Laboratory Test Findings a) Platelet count <100,000/mm3 or hemoglobin <9 g/dL b) Serum creatinine >2.5 mg/dL [221 umol/L] or a calculated creatinine clearance <25 ml/min. c) ALT or AST >2 times upper limit of normal, or a total bilirubin >1.5 times upper limit of normal (unless the latter has an alternative causative factor identified [eg,Gilbert?s syndrome]). 4) Prohibited Treatments and/or Therapies a) Subjects requiring ASA >165 mg/day at randomization. b) Subjects requiring dual anti-platelet therapy (such as ASA plus clopidogrel or ASA plus ticlopidine) at randomization. Subjects who transition from dual antiplatelet therapy to monotherapy prior to randomization will be eligible for the trial. 5) Other Exclusion Criteria a) Prisoners or subjects who are involuntarily incarcerated b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness c) Receiving concurrent investigational agents or has received an investigational agent within the past 30 days prior to the first dose of study treatment (with the exception of approved medications being used for an approved indication, eg, investigating a new dosing regimen for an approved indication); d) Any condition, which in the opinion of the investigator, would put the subject at an unacceptable risk from participating in the study; or e) Any other medical, social, logistical, or psychological reason, which in the opinion of the investigator, would preclude compliance with, or succ
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method