A Safety and Efficacy Trial Evaluating the Use of Apixaban in the Treatment of Symptomatic Deep Vein Thrombosis and Pulmonary Embolism
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5,614
- 试验地点
- 74
- 主要终点
- Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
研究概览
简要总结
The purpose of this study is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients with deep vein thrombosis (DVT) or pulmonary embolism (PE)
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women ≥ 18 years of age
- •Clinical diagnosis of DVT or PE
排除标准
- •Contraindications for enoxaparin or warfarin
- •Active bleeding or high risk for serious bleeding
- •Short life expectancy
- •Uncontrolled high blood pressure
- •Significantly impaired kidney or liver function
研究组 & 干预措施
Apixaban
apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
干预措施: Enoxaparin (Drug)
Apixaban
apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
干预措施: warfarin (Drug)
Enoxaparin + Warfarin
Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
干预措施: apixaban (Drug)
Apixaban
apixaban: tablets, oral, 10 milligram (mg) tablets, twice daily, for 7 days followed by apixaban 5 mg, twice daily, 6 months.
干预措施: Placebo for apixaban (Drug)
Enoxaparin + Warfarin
Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
干预措施: Placebo for enoxaparin (Drug)
Enoxaparin + Warfarin
Enoxaparin: solution, subcutaneous, 1 mg/kg Q12h until international normalized ratio (INR) ≥2.
干预措施: Placebo for warfarin (Drug)
结局指标
主要结局
Incidence of Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or VTE-Related Death During 6 Months of Treatment
时间窗: Day 1 to Week 24 + 2 Days or 355 days (Discontinued Early)
VTE: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All events were adjudicated by an ICAC blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants): n/N (n=number of participants with observation; N=total number of efficacy evaluable participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint: events at any time from randomization until end of intended treatment, regardless whether drug treatment was received. All randomized participants with a non-missing primary endpoint were summarized. Missing endpoint = outcomes which could not be documented on or after study Day 154. Participants were categorized to the assigned group regardless of the treatment actually received (intent-to-treat).
次要结局
- Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or VTE-related Death or Major Bleeding(Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Symptomatic Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period(Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Composite of Recurrent Symptomatic Venous Thromboembolism (VTE) or All-Cause Death(Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Composite of Recurrent Symptomatic VTE or Cardiovascular (CV)-Related Death(Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Composite of Recurrent Symptomatic VTE, Myocardial Infarction, Stroke, CV-related Death, Clinically Relevant Non-major (CRNM) Bleeding or Major Bleeding(Day 1 up to 24 Weeks + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Symptomatic Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period(Day 1 to Week 24 + + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Venous Thromboembolism (VTE)-Related Death During the Intended Treatment Period(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of Cardiovascular (CV)-Related Death Including VTE-related Death During the Intended Treatment Period(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of All-Cause Death During the Intended Treatment Period(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Major Bleeding During the Treatment Period in Treated Participants(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Clinically Relevant Non Major (CRNM) Bleeding During the Treatment Period in Treated Participants(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Minor Bleeding During the Treatment Period in Treated Participants(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Total Bleeding During the Treatment Period in Treated Participants(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Discontinuations Due to AEs and Death During the Treatment Period in Treated Participants(First dose to last dose of 24 Weeks + 2 days (AEs) or + 30 days (SAEs) or until drug discontinued)
- Number of Treated Participants With Marked Abnormalities in Hematology Laboratory Tests(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Number of Treated Participants With Marked Abnormalities in Electrolyte Laboratory Tests(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Number of Treated Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Incidence of Adjudicated Major/CRNM Bleeding During the Treatment Period in Treated Participants(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Number of Treated Participants With Marked Abnormalities in Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))
- Number of Treated Participants With Marked Abnormalities in Urinalysis Laboratory Tests(Day 1 to Week 24 + 2 Days or 355 Days (Discontinued Early))