Clinical trial NCT05892042: Anti-CoagulaTion on Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
Official title: Assessment of Anti-Coagulation Therapy on Patient With Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Left Ventricular Thrombus
Keywords: STEMI, LVT, Anticoagulation
Lead sponsor: Jilin University
Sponsor class: OTHER
First posted: 2023-06-07
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Acute ST segment elevation myocardial infarction complicated with left ventricular thrombus weather or not treated with primary PCI.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of participants with the first occurrence of Stroke and other systemic embolism
timeFrame: 12 months
Secondary outcomes:
measure: Composite major adverse events
timeFrame: 12 months
measure: LVT resolution
timeFrame: 12 months
measure: Total LVT present time
timeFrame: 12 months
measure: Percentage of Participants With Clinically Significant Bleeding
timeFrame: 12 months
measure: Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
timeFrame: 12 months
measure: Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
timeFrame: 12 months
measure: cardiac death
timeFrame: 12 months
Other outcomes:
Locations:
city: Chang chun
country: China
facility: Jilin university
state: Jilin
Study officials:
affiliation: The First Hospital of Jilin University
name: Mingyou Zhang
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Neskovic AN, Marinkovic J, Bojic M, Popovic AD. Predictors of left ventricular thrombus formation and disappearance after anterior wall myocardial infarction. Eur Heart J. 1998 Jun;19(6):908-16. doi: 10.1053/euhj.1998.0871.
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