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ST-segment Elevation Myocardial Infarction (STEMI)ACTonLVTNCT05892042

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

A study testing Rivaroxaban 15 MG [Xarelto] in people with ST-segment Elevation Myocardial Infarction (STEMI) and Left Ventricular Thrombus, run by Jilin University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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

Who is it for?
Ages 18 to 80 years
What is being tested?
Rivaroxaban 15 MG [Xarelto]
Could I receive a placebo?
No, everyone receives an active treatment
How many people
320 participants
Where
1 siteChina
Study dates
1 May 2023to 1 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mingyou Zhang contact

86-431-88782342

zmy@jlu.edu.cn

Zhaoxi Liu contact

86-431-88782342

China1 site, 1 recruiting

  • Jilin university

    Changchun, Jilin, 130000

    Mingyou Zhang

    Recruiting

Other trials in China

About this study

Official title: Assessment of Anti-Coagulation Therapy on Patient With 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

Read the 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.

Being tested
Rivaroxaban 15 MG [Xarelto]
Keywords
STEMI, LVT, Anticoagulation
Medical subject headings
ST Elevation Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rivaroxaban 15 MG [Xarelto]Drug

    Also called Xarelto

    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.

Study groups in NCT05892042
Study groupRoleWhat they receive
interventionExperimentalpatient 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.
Receives: Drug: Rivaroxaban 15 MG [Xarelto]
controlNo interventionpatient will receive dual antiplatelet therapy, the choose of p2Y12 inhibitor is at the discretion of the clinician.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 12 months

Secondary outcomes (7)

  1. Composite major adverse events

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

    Measured: 12months

  2. LVT resolution

    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.

    Measured: 12 months

  3. Total LVT present time

    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.

    Measured: 12 months

  4. Percentage of Participants With Clinically Significant Bleeding

    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.

    Measured: 12 months

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

    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

    Measured: 12 months

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

    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

    Measured: 12 months

  7. cardiac death

    cardiac death

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2023
  2. Study start1 May 2023
  3. Primary completion1 Sep 2026 (estimated)
  4. Study completion1 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Acute ST segment elevation myocardial infarction complicated with left ventricular thrombus weather or not treated with primary PCI.
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05892042
Sponsor's protocol ID
ACT on LVT
Acronym
ACTonLVT
Status last verified
May 2026
First submitted
28 May 2023
Last updated
1 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Delewi R, Zijlstra F, Piek JJ. Left ventricular thrombus formation after acute myocardial infarction. Heart. 2012 Dec;98(23):1743-9. doi: 10.1136/heartjnl-2012-301962. No abstract available.

    PubMed 23151669

  • Lattuca B, Bouziri N, Kerneis M, Portal JJ, Zhou J, Hauguel-Moreau M, Mameri A, Zeitouni M, Guedeney P, Hammoudi N, Isnard R, Pousset F, Collet JP, Vicaut E, Montalescot G, Silvain J; ACTION Study Group. Antithrombotic Therapy for Patients With Left Ventricular Mural Thrombus. J Am Coll Cardiol. 2020 Apr 14;75(14):1676-1685. doi: 10.1016/j.jacc.2020.01.057.

    PubMed 32273033

  • Kontny F, Dale J, Hegrenaes L, Lem P, Soberg T, Morstol T. Left ventricular thrombosis and arterial embolism after thrombolysis in acute anterior myocardial infarction: predictors and effects of adjunctive antithrombotic therapy. Eur Heart J. 1993 Nov;14(11):1489-92. doi: 10.1093/eurheartj/14.11.1489.

    PubMed 8299630

  • 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.

    PubMed 9651715

  • Nadareishvili ZG, Choudary Z, Joyner C, Brodie D, Norris JW. Cerebral microembolism in acute myocardial infarction. Stroke. 1999 Dec;30(12):2679-82. doi: 10.1161/01.str.30.12.2679.

    PubMed 10582996

Questions about this trial

What is this clinical trial studying?

A study testing Rivaroxaban 15 MG [Xarelto] in people with ST-segment Elevation Myocardial Infarction (STEMI) and Left Ventricular Thrombus, run by Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mingyou Zhang (86-431-88782342, zmy@jlu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with the first occurrence of Stroke and other systemic embolism (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05892042, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.

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