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临床试验/NCT05892042
NCT05892042招募中不适用

Assessment of Anti-Coagulation Therapy on Patient With Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction

Jilin University1 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2023年5月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
320
试验地点
1
主要终点
Percentage of participants with the first occurrence of Stroke and other systemic embolism

研究概览

简要总结

Contemporary data are lacking regarding the management of left ventricular thrombus (LVT) developed after ST segment elevation myocardial infarction

详细描述

Left ventricular thrombus (LVT) is a commom complication after ST segment elevation myocardial infarction (STEMI), reperfusion therapy have reduced the incidence of LVT, however, about 6% of all STEMI patients will develop LVT. the risk of LVT development in anterior STEMI with reduced LVEF are as high as 20%. Although current guideline recommend anti-coagulation therapy, but the evidence still based on observational data, there has been inconsistency with the benefit of the coagulation therapy, give the significant increased bleeding risk by superimpose anti-coagulation therapy to the dual anti-platelet therapy. especially in the era of more potent anti-platelet P2Y12 inhibitor widely used clinical. the mechanism of LVT is different from that of the atrial fibrillation in which the risk of systemic embolism is persistent, coagulation bring absolute clinical benefit for high risk patients. however, for LVT developed following STEMI tend to be temporary, majority of thrombus resolve within 1-3 months after STEMI event. more likely a reflection of coagulation system in response to the necrosis of infarct myocardium. The optimal management in LVT after STEMI warrants further exploration. the desiring of randomized controlled clinical trial to compare dual anti platelet + anti-coagulation and dual anti-platelet without anti-coagulation in patient LVT are justified.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Established ST segment elevation myocardial infarction within 7 days Left ventricular thrombus (LVT) is detected by either cardiac magnetic resonance (CMR) or TTE.
  • Ongoing treatment with dual anti-platelet therapy according to ESC/AHA guidelines at the time of randomization

排除标准

  • Clinically or hemodynamically unstable planed major surgeon such as CABG or Valve replacement within next 12 months Concomitant condition that requires anti- coagulation therapy, such as AF, DVT.
  • Any contraindication of anticoagulant therapy History of intracranial hemorrhage; Woman who is currently pregnant, or breastfeeding serious impaired renal and liver functions life expectancy less than 1 year can not provide consent

研究组 & 干预措施

intervention

Experimental

patient will receive dual antiplatelet therapy, the choose of p2Y12 inhibitor is at the discretion of the clinician. in addition the patient will receive rivaroxaban 15mg daily in addition to the dual antiplatelet therapy.

干预措施: Rivaroxaban 15 MG [Xarelto] (Drug)

结局指标

主要结局

Percentage of participants with the first occurrence of Stroke and other systemic embolism

时间窗: 12 months

The percentage of participants with the first occurrence of Stroke and other systemic embolism were evaluated.

次要结局

  • cardiac death(12 months)
  • Composite major adverse events(12 months)
  • Percentage of Participants With Clinically Significant Bleeding(12 months)
  • Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding(12 months)
  • Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding(12 months)
  • LVT resolution(12 months)
  • Total LVT present time(12 months)

研究者

发起方
Jilin University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mingyou Zhang

Associate prof

Jilin University

研究点 (1)

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