Pulmonary Embolism & Anticoagulation Evaluation in Cancer Patient - PEACE
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 234
- 试验地点
- 6
- 主要终点
- WIN ratio of a composite hierarchical endpoint assessed over follow-up including: 1) all-cause mortality 2) clinical pulmonary embolism verified by imaging 3) major bleeding as defined by the International Society on Thrombosis and Haemostasis 4) clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis
研究概览
简要总结
To compare withholding anticoagulant treatment versus initiating anticoagulant treatment in cancer patients with incidental subsegmental pulmonary embolism, measuring mortality, bleeding, re-thrombosis, cancer treatment continuation, and quality of life.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •1 Active cancer
- •2 Age more than or equal to 18
- •3 Less than or equal to three incidental SSPEs detected on routine imaging
- •4 Planned routine follow-up CT scan within 3-4 months
- •5 Able to provide informed consent
- •6 Access to smartphone (participant or family member)
排除标准
- •1 Other indications for anticoagulation treatment
- •2 Currently receiving anticoagulation treatment
- •3 Clinical signs of deep venous thrombosis
- •4 Previous venous thromboembolism (within 10 years)
- •5 Immobilisation > 5 consecutive days
- •6 Cancer surgery within the past 1 month
- •7 Inability to read and speak Danish sufficiently for informed consent and study participation
- •8 Pregnancy
研究组 & 干预措施
TINZAPARIN
干预措施: TINZAPARIN (Drug)
RIVAROXABAN
干预措施: RIVAROXABAN (Drug)
EDOXABAN
干预措施: EDOXABAN (Drug)
ENOXAPARIN
干预措施: ENOXAPARIN (Drug)
APIXABAN
干预措施: APIXABAN (Drug)
DALTEPARIN
干预措施: DALTEPARIN (Drug)
结局指标
主要结局
WIN ratio of a composite hierarchical endpoint assessed over follow-up including: 1) all-cause mortality 2) clinical pulmonary embolism verified by imaging 3) major bleeding as defined by the International Society on Thrombosis and Haemostasis 4) clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis
WIN ratio of a composite hierarchical endpoint assessed over follow-up including: 1) all-cause mortality 2) clinical pulmonary embolism verified by imaging 3) major bleeding as defined by the International Society on Thrombosis and Haemostasis 4) clinically relevant non-major bleeding as defined by the International Society on Thrombosis and Haemostasis
次要结局
- Clinically relevant bleeding (major bleeding + CRNMB based on the ISTH- definition)
- Venous thromboembolism other than pulmonary embolism verified by imaging
- Progression, stability or resolution of thrombosis on imaging, assessed by two independent radiologists
- Discontinuation of cancer treatment related to pulmonary embolism or pulmonary embolism treatment
- Quality of life assessed by the EuroQol 5-Dimension 5-level (EQ-5D-5L), pulmonary embolism quality of life questionnaire (PEmb-QoL) and the European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ C30)
研究者
Ali Al-Alak
Scientific
Region Hovedstaden