A Randomised Pilot Study Assessing the Optimal Duration of Anticoagulation for Left Ventricular Thrombus
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Stroke and Systemic Embolism (SSE)
研究概览
简要总结
The LVT DURATION (Optimal Duration of Anticoagulation for LV Thrombus) is a pilot study planned to assess the practicalities of conducting a randomised control trial (RCT) whilst establishing data around the ideal duration of anticoagulation in the treatment of LV thrombus. The main objectives of the study are:
- To assess the practicalities of conducting an RCT with regard to recruitment, retention, and outcome measurement.
- To identify the optimal length of anticoagulation in the treatment of LV Thrombus
After randomisation participants will:
- Continue their prescribed oral anticoagulant for the remainder of the trial
- Discontinue their prescribed oral anticoagulant for the remainder of the trial
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
- •Diagnosis of LV thrombus less than 12 months ago
- •On Apixaban at the time of randomisation
- •Completed at least 3 months of anticoagulation treatment for LV thrombus
- •Persistent laminar/ mural thrombus or persistent LV dysfunction
排除标准
- •Any clinical condition requiring long term anticoagulation treatment as per investigator's judgement.
- •SSE since LV thrombus diagnosis
- •Contraindication to continuing anticoagulation therapy
- •Non-ischaemic Cardiomyopathy
- •Age less than 18 years
- •Unable to consent
研究组 & 干预措施
Continue pre prescribed rivaroxaban or apixaban or warfarin
If randomised to this arm, participants will continue on their rivaroxaban or apixaban or warfarin for the study related time period.
干预措施: Continue rivaroxaban or apixaban or warfarin (Drug)
Discontinue pre prescribed rivaroxaban or apixaban or warfarin
If randomised to this arm, patients (who have already been on OAC for a period of 3 months) will discontinue their rivaroxaban or apixaban or warfarin.
干预措施: Discontinue rivaroxaban or apixaban or warfarin (Drug)
结局指标
主要结局
Stroke and Systemic Embolism (SSE)
时间窗: 6 months
Number of SSE events following randomisation
All-Cause Mortality
时间窗: 6 months
Number of deaths from any cause following randomisation
次要结局
- Major Bleeding(6 months)
- Minor Bleeding(6 months.)
- New LV Thrombi(6 months)
- Resolved Thrombus(6 months)
- Hospitalisation(6 months)
- Cost Comparison(6 months)
- MI(6 months)
- EQ-5D-5L(6 months)
- Perspectives of Clinicians and Patients(6 months)
- Target Vessel Revascularization (TVR)(6 months)