Assessment of Anti-Coagulation Therapy on Patient With Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
Overview
- Phase
- Not Applicable
- Intervention
- Rivaroxaban 15 MG [Xarelto]
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Sponsor
- Jilin University
- Enrollment
- 320
- Locations
- 1
- Primary Endpoint
- Percentage of participants with the first occurrence of Stroke and other systemic embolism
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Contemporary data are lacking regarding the management of left ventricular thrombus (LVT) developed after ST segment elevation myocardial infarction
Detailed Description
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.
Investigators
Mingyou Zhang
Associate prof
Jilin University
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
intervention
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.
Intervention: Rivaroxaban 15 MG [Xarelto]
Outcomes
Primary Outcomes
Percentage of participants with the first occurrence of Stroke and other systemic embolism
Time Frame: 12 months
The percentage of participants with the first occurrence of Stroke and other systemic embolism were evaluated.
Secondary Outcomes
- 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)