STOPping Anticoagulation for Isolated or Incidental Subsegmental Pulmonary Embolism
试验速览
- 阶段
- 3 期
- 入组人数
- 1,466
- 试验地点
- 1
- 主要终点
- A composite score of the number of recurrent venous thromboembolism and/or clinically relevant bleeding
研究概览
简要总结
Pulmonary embolisms (PE) occur when blood clots cause a blockage of the blood supply to the lungs. A small PE located in the subsegmental pulmonary vasculature is identified as a subsegmental PE (SSPE). Anticoagulants are used to treat SSPE and work by preventing new clots from forming whilst the body's own mechanisms break down the clots, however they can also increase the risk of major and potentially life threatening bleeding. More recent observational data of routine care for SSPE showed very high complication rates of anticoagulation but in patients where treatment was withheld, this proved to be a safe strategy in terms of recurrent venous thromboembolism (VTE).
Computed tomography pulmonary angiography (CTPA) scans are now able to detect SSPE, however there are concerns that there is an over-diagnosis due to the incorrect interpretation of small artefacts. 1466 patients from approximately 50 sites will be recruited, these sites will consist of hospitals across the United Kingdom (UK). Patients 18 and over with isolated SSPE, confirmed by either CTPA or CT thorax with IV contrast, will be eligible for the trial. Patients will be randomised to either receive standard anticoagulation for at least 3 months (control) or no anticoagulation for at least 3 months (intervention). The participant will receive telephone follow up calls at 4, 12 and 24 weeks following the end of their treatment, and additional data will also be taken from their medical records at these time points. The participant isn't required to be contacted for the 52 week follow up as the data will be extracted from the National Health Service (NHS) Digital collection of Hospital Episode Statistics (HES). In total participation in the study will last 12 months. In addition the cost-effectiveness of no treatment versus treatment with full anticoagulation will be looked at and also improving on radiological diagnosis of SSPE.
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
- 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
- •Age ≥18 years
- •SSPE diagnosed by the radiologist at the trial site by CTPA or CT thorax with IV contrast
- •No evidence of proximal deep vein thrombosis on doppler ultrasonography or CT / Magnetic Resonance venography
- •Heart rate (<110bpm)
- •Systolic blood pressure (≥100 mmHg)
- •Oxygen saturation (≥90%)
- •Written signed informed consent to the trial
排除标准
- •Indication for hospital admission
- •>7 days empirical anticoagulation treatment immediately prior to randomisation
- •<28 days since first symptoms of proven or clinically suspected Coronavirus disease (COVID-19)
- •Known stage 5 chronic kidney disease
- •Patients with active cancer defined as cancer diagnosed within the past 6 months, cancer for which anticancer treatment was being given at the time of enrolment or during 6 months before randomisation, or recurrent locally advanced or metastatic cancer
- •Patients with previous unprovoked PE, thrombophilia or requiring long term anticoagulation for another reason
- •Patients with a Deep Vein Thrombosis / thrombus of an unusual site (e.g. upper limbs, associated with a line) that requires anticoagulation
- •Patients with active bleeding
- •Any condition which, in the opinion of the investigator, makes the participant unsuitable for trial entry due to prognosis/terminal illness with a projected survival of less than 3 months
- •Pregnancy confirmed by positive pregnancy test or post-partum period or actively trying to conceive
- •Inability to comply with the trial schedule and follow-up
- •Participation in a Clinical Trial of Investigative Medicinal Product (CTIMP) study
研究组 & 干预措施
Control
Full dose anticoagulation treatment as standard care for at least 3 months.
干预措施: Warfarin (Drug)
Control
Full dose anticoagulation treatment as standard care for at least 3 months.
干预措施: direct oral anticoagulants (Drug)
Control
Full dose anticoagulation treatment as standard care for at least 3 months.
干预措施: Low molecular weight heparin (Drug)
Intervention
Withholding anticoagulation for Isolated Sub-Segmental Pulmonary Embolism (ISSPE) for at least 3 months.
干预措施: No treatment (Other)
结局指标
主要结局
A composite score of the number of recurrent venous thromboembolism and/or clinically relevant bleeding
时间窗: 3 months
To determine if withholding anticoagulation is non-inferior to standard anticoagulation therapy in the treatment of isolated or incidental subsegmental pulmonary embolism for preventing recurrent venous thromboembolism, and/or death related and non death related venous thromboembolism, or superior for clinically relevant bleeding over 3 months, compared with at least 3 months of full anticoagulation. This will be measured using a scoring system which is currently being developed by the statistical team, and will be detailed in the statistical analysis plan when finalised.
次要结局
- Measuring the rate of net clinical benefit(3 and 6 months)
- Number of new diagnosis of pulmonary hypertension of right ventricular dysfunction identified from Hospital Episode Statistics.(12 months)
- The change in frequency and severity of harmful events(6 and 12 months)
- Reclassification rate from thoracic radiologist review(32 months)
- Measuring the rate of mortality(3, 6 and 12 months)