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
- 1
- 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 prior to enrollment for any reasons, except for participants who were transitioned to apixaban dosing regimen consistent with the protocol (2.5 mg twice daily) for ≤ 3 days .
- •Known contraindication for apixaban, such as allergy, hypersensitivity, or pregnancy.
- •Concomitant use of strong inhibitors or inducers of both cytochrome P450 3A4 (enzyme) and P-glycoprotein.
研究组 & 干预措施
Apixaban
2.5 mg twice daily
干预措施: Apixaban (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)