Secondary Prevention of Venous Thromboembolism in Patients With Cancer and Catheter-Related Upper Extremity Deep Vein Thrombosis (STREAM-Line Study)
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 330
- 试验地点
- 2
- 主要终点
- Venous Thromboembolism (VTE) Rate
研究概览
简要总结
This trial seeks to evaluate a management strategy after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) for patients with cancer and catheter-related upper extremity deep vein thrombosis (DVT).
详细描述
The aim of the STREAM-Line Trial is to demonstrate that the STREAM-Line management strategy is safe after the acute treatment duration (≥ 3 months of therapeutic anticoagulation) in patients with cancer and catheter-related upper extremity DVT. Upon enrollment and during follow-up, patients will be managed with a prophylactic dose of apixaban (2.5 mg orally twice daily) as long as either a central venous catheter (CVC) or active cancer is present (STREAM-Line management strategy). Apixaban will be stopped at the time of CVC removal and when cancer is in remission. Day 90±14 and Day 180+14 follow-up visit procedures will be done by phone call or in person.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Adult patients (≥ 18 years old) with active cancer, defined as cancer (other than localized non-melanoma skin cancer) diagnosed or treated within 6 months, or the presence of metastatic, recurrent, or progressive malignancy, ongoing anticancer therapy, or hematological malignancy not in complete remission.
- •Objectively confirmed catheter-related upper extremity DVT and treated with any standard therapeutic anticoagulation (including LMWH dose reduction to 75% after the first month) for at least 3 months.
- •Able and willing to provide informed consent.
排除标准
- •Active bleeding or other reasons for which anticoagulation is contraindicated.
- •Other indications requiring ongoing therapeutic dose of anticoagulation as deemed necessary by treating physicians (such as atrial fibrillation, mechanical heart valve, etc.).
- •Anticoagulation has been permanently stopped or reduced to prophylactic dose for > 5 days prior to enrollment for any reasons.
- •Pregnancy or breast feeding in patients who are prescribed a direct oral anticoagulant.
- •Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 and P-glycoprotein in patients who are prescribed a direct oral anticoagulant.
- •Cancer is in remission and CVC is removed prior to enrollment.
- •Requirement of dual antiplatelet therapies.
- •Platelet count < 50 x 109/L or creatinine clearance < 30 ml/min.
- •Life expectancy of less than 3 months.
研究组 & 干预措施
Apixaban
2.5 mg twice daily
干预措施: Anticoagulation Therapy (Drug)
结局指标
主要结局
Venous Thromboembolism (VTE) Rate
时间窗: 6 months
The rates of symptomatic, objectively confirmed new or recurrent major VTE (proximal upper or lower extremity DVT, segmental or larger pulmonary embolism (PE)) with corresponding 95% Confidence Interval (CI) at 6 months.
次要结局
- Major Venous Thromboembolism (VTE) and Major bleeding Rate(3 months)
- New/recurrent symptomatic catheter-related upper extremity Deep Vein Thrombosis (DVT).(3 months and 6 months)
- New incidental Venous Thromboembolism (VTE)(3 months and 6 months)
- New Deep Vein Thrombosis (DVT)(3 months and 6 months)
- Superficial vein thrombosis of upper or lower extremities(3 months and 6 months)
- New unusual site Venous Thromboembolism (VTE)(3 months and 6 months)
- Clinically Relevant Non-Major Bleeding (CRNMB) events(3 months and 6 months)
- Arterial thromboembolic events(3 months and 6 months)
- All-cause mortality(3 months and 6 months)
- Correlative biomarkers(6 months)
- Health-related quality of life using the EuroQoL-5D-5L Questionnaire(6 months)