NCT00252005已完成2 期
Protocol CV185017: A Phase 2 Randomized, Parallel-Arm Study of Oral Direct Factor Xa-Inhibitor Apixaban and Low Molecular Weight Heparin or Fondaparinux With A Vitamin K Antagonist In Subjects With Acute Symptomatic Deep-Vein Thrombosis
Bristol-Myers Squibb73 个研究点 分布在 9 个国家目标入组 520 人开始时间: 2005年11月最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 520
- 试验地点
- 73
- 主要终点
- The composite of symptomatic recurrent venous thromboembolism (i.e., recurrent deep-vein thrombosis or fatal or non-fatal pulmonary embolism and deterioration of the thrombotic burden as assessed by repeat bilateral
研究概览
简要总结
The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must be willing and able to give written informed consent.
- •Confirmed acute symptomatic DVT, i.e., proximal vein or extensive calf-vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation area) without concomitant symptomatic PE.
- •Women and men, ages 18 (or legal age of consent) to
- •Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 1 week after the study in such a manner that the risk of pregnancy is minimized.
- •WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.
排除标准
- •Women who are pregnant or breastfeeding.
- •Women with a positive pregnancy test on enrollment or prior to study drug administration.
- •More than 24 hours pre-randomization treatment with therapeutic dosages of unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or more than a single starting dose of vitamin K antagonist (VKA) prior to randomization.
- •Uncontrolled hypertension: systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg.
- •Creatinine clearance < 30 mL/min
- •Impaired liver function (ALT > 3 x ULN)
- •Use of ASA > 165 mg/day
- •WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 1 week after the study.
- •Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin).
- •NOTE: topical azole antifungal agents are permitted.
结局指标
主要结局
The composite of symptomatic recurrent venous thromboembolism (i.e., recurrent deep-vein thrombosis or fatal or non-fatal pulmonary embolism and deterioration of the thrombotic burden as assessed by repeat bilateral
compression ultrasound and perfusion lung scan.
次要结局
未报告次要终点
研究者
研究点 (73)
Loading locations...
相似试验
已完成
3 期
Apixaban in Preventing Secondary Cancer Related Venous Thrombosis in Cancer Patients Who Have Completed Anticoagulation TherapyCerebral Vein ThrombosisDeep Vein ThrombosisHematopoietic and Lymphoid Cell NeoplasmMalignant Solid NeoplasmMetastatic Malignant Solid NeoplasmSplanchnic Vein ThrombosisPulmonary EmbolismNCT03080883Academic and Community Cancer Research United370
已完成
2 期
A Trial of 2 Schedules of Ixabepilone Plus Bevacizumab and Paclitaxel Plus Bevacizumab for Breast CancerMetastatic Breast CancerNCT00370552R-Pharm136
终止
4 期
Calf Deep Vein Thrombosis Treatment TrialDeep Vein ThrombosisNCT03590743Mayo Clinic5
终止
2 期
Efficacy and Safety Study of Abatacept to Treat Lupus NephritisSystemic Lupus ErythematosusNCT00430677Bristol-Myers Squibb423
进行中（未招募）
2 期
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate CancerProstate CancerNCT03706365Eli Lilly and Company393