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

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI), Left Ventricular Thrombus

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Rivaroxaban 15 MG [Xarelto]
Sponsored by
Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring STEMI, LVT, Anticoagulation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jilin universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention

control

Arm Description

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.

patient will receive dual antiplatelet therapy, the choose of p2Y12 inhibitor is at the discretion of the clinician.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
May 28, 2023
Last Updated
May 28, 2023
Sponsor
Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT05892042
Brief Title
Anti-CoagulaTion on Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
Acronym
ACTonLVT
Official Title
Assessment of Anti-Coagulation Therapy on Patient With Left Ventricular Thrombus After ST Segment Elevation Myocardial Infarction
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jilin University

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI), Left Ventricular Thrombus
Keywords
STEMI, LVT, Anticoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Acute ST segment elevation myocardial infarction complicated with left ventricular thrombus weather or not treated with primary PCI.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
patient will receive dual antiplatelet therapy, the choose of p2Y12 inhibitor is at the discretion of the clinician.
Intervention Type
Drug
Intervention Name(s)
Rivaroxaban 15 MG [Xarelto]
Other Intervention Name(s)
Xarelto
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of participants with the first occurrence of Stroke and other systemic embolism
Description
The percentage of participants with the first occurrence of Stroke and other systemic embolism were evaluated.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Composite major adverse events
Description
The incidence of a composite adverse events, including all cause mortality, recurrent myocardial infarction, ischemic stroke and other systemic embolism
Time Frame
12 months
Title
LVT resolution
Description
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.
Time Frame
12 months
Title
Total LVT present time
Description
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.
Time Frame
12 months
Title
Percentage of Participants With Clinically Significant Bleeding
Description
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.
Time Frame
12 months
Title
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding
Description
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
Time Frame
12 months
Title
Percentage of Participants With Thrombolysis in Myocardial Infarction (TIMI) Minor Bleeding
Description
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
Time Frame
12 months
Title
cardiac death
Description
cardiac death
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mingyou Zhang
Phone
86-431-88782342
Email
zmy@jlu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Zhaoxi Liu
Phone
86-431-88782342
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mingyou Zhang
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jilin university
City
Chang chun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mingyou Zhang

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23151669
Citation
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.
Results Reference
background
PubMed Identifier
32273033
Citation
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.
Results Reference
background
PubMed Identifier
8299630
Citation
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.
Results Reference
background
PubMed Identifier
9651715
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.
Results Reference
background
PubMed Identifier
10582996
Citation
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.
Results Reference
background

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

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