A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of 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
- 2,711
- 试验地点
- 87
- 主要终点
- Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
研究概览
简要总结
The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for 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 Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);
- •Anticoagulant treatment completed
- •No recurrence of Venous Thromboembolism (VTE)
排除标准
- •Subjects with indications for long-term treatment with a vitamin K antagonist
- •Active bleeding or high risk for serious bleeding
- •Short life expectancy
- •Uncontrolled high blood pressure
- •Impaired kidney or liver function
研究组 & 干预措施
1
2.5 mg
干预措施: Apixaban (Drug)
2
5.0 mg
干预措施: Apixaban (Drug)
3
0 mg
干预措施: Placebo (Drug)
结局指标
主要结局
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation
时间窗: Day 1 up to 12 Months
VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee 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 with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.
Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation
时间窗: Day 1 up to 12 months
VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.
次要结局
- Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants(Day 1 up to 12 Months)
- Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation(Day 1 up to 12 Months)
- Adjudicated Total Bleeding During the Treatment Period - Treated Participants(Day 1 up to 12 months)
- Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)
- Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation(Day 1 up to 12 Months)
- Adjudicated Major Bleeding During the Treatment Period - Treated Population(Day 1 up to 12 Months)
- Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)
- Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants(Day 1 up to 12 months)
- Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)
- Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants(Day 1 up to 12 months)
- Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)
- Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)
- Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)
- Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation(Day 1 up to 12 Months)