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NCT Number: NCT05892042

Anti-CoagulaTion on Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction

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

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Key information

Conditions

ST-segment Elevation Myocardial Infarction (STEMI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Left Ventricular Thrombus Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jilin university

Changchun, Jilin, 130000, China

Location status: Recruiting

Location contact

Mingyou Zhang

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivaroxaban 15 MG [Xarelto]

Drug

Eligible subjects randomized into experimental group will receive rivaroxaban 15mg daily in addition to dual anti platelet therapy unless confirmed resolution of the left ventricular thrombus.

Other names: Xarelto

Primary outcomes

  1. 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

  1. Composite major adverse events

    Time frame: 12months

    The incidence of a composite adverse events, including all cause mortality, recurrent myocardial infarction, ischemic stroke and other systemic embolism

  2. LVT resolution

    Time frame: 12 months

    the LVT resolve will be determined monthly by follow-up imaging examination (Echo cardiograph or Cardiac magnetic resonance). The percentage of LVT resolve at 3 months will be calculated for each group.

  3. Total LVT present time

    Time frame: 12 months

    LVT will be followed every month in the first 3 months, every 3 months thereafter to determine the present of LVT by Echo cardiograph or Cardiac magnetic resonance.

  4. Percentage of Participants With Clinically Significant Bleeding

    Time frame: 12 months

    Clinically significant bleeding is a composite of Thrombolysis in Myocardial Infarction (TIMI) major bleeding, minor bleeding, and bleeding requiring medical attention (BRMA). TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of greater than or equal to (>=) 5 grams per deciliter (g/dL) (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent (%)). TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to less than (<) 5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent). A BRMA event is defined as any bleeding event that requires medical treatment, surgical treatment, or laboratory evaluation, and does not meet criteria for a major or minor bleeding event.

  5. Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding

    Time frame: 12 months

    TIMI major bleeding is defined as any symptomatic intracranial hemorrhage, Clinically overt signs of hemorrhage (including imaging) associated with a drop in hemoglobin of >= 5 g/dL (or when the hemoglobin concentration is not available, an absolute drop in hematocrit of >=15 percent

  6. Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding

    Time frame: 12 months

    TIMI minor bleeding event is defined as any clinically overt sign of hemorrhage (including imaging) that is associated with a fall in hemoglobin concentration of 3 to <5 g/dL (or, when hemoglobin concentration is not available, a fall in hematocrit of 9 percent to <15 percent

  7. cardiac death

    Time frame: 12 months

    cardiac death

Study contacts

Contact information is provided by the study sponsor or research team.

Mingyou Zhang

CONTACT

[email protected]

86-431-88782342

Zhaoxi Liu

CONTACT

86-431-88782342

Sponsors and collaborators

Lead sponsor

Jilin University

Other

Registry information

Official study title

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

Acronym: ACTonLVT

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 7, 2023
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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