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

NCT05892042 | Unknown DMC

• 1 other identifier: ACT on LVT
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

STEMI, LVT, Anticoagulation

Outcome Measures

Primary Outcomes (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.

  12 months

Secondary Outcomes (7)

• Composite major adverse events

  12 months

• LVT resolution

  12 months

• Total LVT present time

  12 months

• Percentage of Participants With Clinically Significant Bleeding

  12 months

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

  12 months

Study Arms (2)

intervention

EXPERIMENTAL

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]

control

NO INTERVENTION

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

Interventions

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.

Also known as: Xarelto

intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jilin University: lead

Study Sites (1)

Jilin university

Changchun, Jilin, 130000, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 23151669 BACKGROUND

• 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.

  PMID: 32273033 BACKGROUND

• 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.

  PMID: 8299630 BACKGROUND

• 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.

  PMID: 9651715 BACKGROUND

• 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.

  PMID: 10582996 BACKGROUND

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mingyou Zhang

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyou Zhang

CONTACT

86-431-88782342; zmy@jlu.edu.cn

Zhaoxi Liu

CONTACT

86-431-88782342

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate prof

Model Details: Acute ST segment elevation myocardial infarction complicated with left ventricular thrombus weather or not treated with primary PCI.

Study Record Dates

• First Submitted: May 28, 2023
• First Posted: June 7, 2023
• Study Start: May 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: April 1, 2025
• Last Updated: June 7, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)