EUCTR2007-007867-25-DE进行中（未招募）不适用
A Safety and Efficacy Trial Evaluating the Use of Apixaban in theTreatment of Symptomatic Deep Vein Thrombosis and PulmonaryEmbolism.Revised Protocol Number 02 incorporating Amendment(s) 04 andAdministrative Letters 02, 03 and 04+ Protocol Amendment 01 (version 1.0 dated 21-Apr-08) Site-specific -Molecular Profiling Supplement Samples For Pfizer's ExploratoryResearch Biobank - AMPLIFY
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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,
- •- ascending contrast venography.
- •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
排除标准
- •1) Sex and Reproductive Status
- •a) WOCBP who are unwilling or unable to use an acceptable method of birth control 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.
- •b) Conditions for which serious bleeding may occur and the time of exclusion relative to the time of randomization: see chart list section 4.2.2.3
- •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 who transition from dual anti-platelet therapy to monotherapy prior to randomization will be eligible for the trial.
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A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary EmbolismRevised Protocol Number: 01, Incorporates amendment(s) 02+ Protocol Amendment 01 (version 1.0 dated 21-Apr-08) Site-specific - Molecular Profiling Supplement Samples For Pfizer’s Exploratory Research BiobankVenous Thromboembolism (VTE)MedDRA version: 9.1Level: PTClassification code 10051055Term: Deep vein thrombosisMedDRA version: 9.1Level: PTClassification code 10037377Term: Pulmonary embolismEUCTR2007-007867-25-PTBristol-Meyers Squibb International Corporation4,816