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

May 28, 2023 updated by: Mingyou Zhang, Jilin University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mingyou Zhang
  • Phone Number: 86-431-88782342
  • Email: zmy@jlu.edu.cn

Study Contact Backup

  • Name: Zhaoxi Liu
  • Phone Number: 86-431-88782342

Study Locations

  • China
    • Jilin
      • Chang chun, Jilin, China, 130000
        • Recruiting
        • Jilin University
        • Contact:
          • Mingyou Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Rivaroxaban 15 MG [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.
Other Names:
  • Xarelto
No Intervention: control
patient will receive dual antiplatelet therapy, the choose of p2Y12 inhibitor is at the discretion of the clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cardiac death
Time Frame: 12 months
cardiac death
12 months
Composite major adverse events
Time Frame: 12 months
The incidence of a composite adverse events, including all cause mortality, recurrent myocardial infarction, ischemic stroke and other systemic embolism
12 months
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.
12 months
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.
12 months
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.
12 months
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
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jilin University

Investigators

  • Principal Investigator: Mingyou Zhang, The First Hospital of Jilin University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

May 28, 2023

First Submitted That Met QC Criteria

May 28, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

June 7, 2023

Last Update Submitted That Met QC Criteria

May 28, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ACT on LVT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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