Anticoagulation in Post MI LV Thrombus Trial in Nepal

NCT05794399 | Recruiting Phase 4 DMC

• 1 other identifier: SGNHC-RCT
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: The prevalence of left ventricular(LV) thrombus after acute myocardial infarction has decreased with thrombolysis and primary angioplasty intervention worldwide. However, most of the patients in our country present late after the onset of ischemia resulting in a comparable increase proportion of late presentation MI compared to developed countries. This delayed presentation is associated with the increased incidence of LV thrombus, associated with increased cerebrovascular and cardiovascular events resulting in increased morbidity and mortality. The Vitamin K Antagonist Warfarin is indicated in recent guidelines for the duration of 3-6 months. The use of Warfarin is less in our part of the world due to the requirement of frequent International Normalized Ration (INR) monitoring and dietary restrictions. Novel oral anticoagulants (NOACs) are an alternate option for such hindrance to the treatment of LV thrombus. This research will help assess the safety and efficacy of Rivaroxaban, one of the NOACs compared to warfarin. Objectives: Our aim will be to compare the efficacy of rivaroxaban compared to warfarin in the complete resolution of post-MI LV thrombus. The primary efficacy endpoint of our study will be a resolution of LV thrombus as assessed by cardiac MRI at the end of 3 months of the study period. The secondary endpoint will be the comparison of the safety of both drugs measured by the incidence of major bleeding and embolic events. Methods: The patients who present late after acute MI in our center with LV thrombus will be enrolled in our study. The diagnosis of LV thrombus will be diagnosed by cardiac MRI, which is considered the gold standard for the diagnosis. The patients then will be randomized in a 1:1 ratio to either warfarin or rivaroxaban within 24 hours of diagnosis of LV thrombus. The warfarin group will be prescribed the warfarin in the dose of 5mg daily and the dose titrated according to the INR value to maintain the INR range of 2 to 3. Rivaroxaban group will be prescribed 15 to 20mg according to the indication. The research group consisting of the principal investigator and coinvestigators will be responsible for the recruitment and overall study procedures.

Conditions

Left Ventricular Thrombus; Myocardial Infarction

Keywords

Post Myocardial Infarction; Left Ventricular Thrombus; Warfarin; Rivaroxaban; Nepal

Outcome Measures

Primary Outcomes (1)

• LV thrombus resolution

  The primary endpoint will be a resolution of LV thrombus as assessed by cardiac MRI in 3 months of study.

  3 months

Secondary Outcomes (2)

• Major bleeding events

  3 months

• Embolic events

  3 months

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

In this arm, the patients with post-myocardial infarction and left ventricular thrombus will be treated with Rivaroxaban 20mg or 15mg as indicated.

Drug: Rivaroxaban

Warfarin

ACTIVE COMPARATOR

In this arm, the patients with post-myocardial infarction and left ventricular thrombus will be treated with warfarin with a dose adjusted with the International Normalised ratio range of 2.0 to 3.0.

Drug: Warfarin

Interventions

Rivaroxaban DRUG

Intervention Group: The patients in the intervention group will be treated with Rivaroxaban 20 mg once daily with the evening meal in patients with a CrCl \>50 mL/min OR 15 mg in cases of moderate-to-severe renal impairment dose with the dosing of once daily with the evening meal in patients with a CrCl ≤50 mL/min. The patient in the intervention group will be requested for follow-up after 3 months of commencing the treatment or whenever the signs and symptoms of bleeding events are noted.

Rivaroxaban

Warfarin DRUG

Control Group: The patients in the control group will be treated with Warfarin. The dose will be started with 5 mg and will be titrated based on the International Normalized Ratio (INR) which will be targeted at the range of 2.0 to 3.0. The dual antiplatelet duration will be based on the latest guidelines. The patients will be asked for frequent INR monitoring on an OPD basis until the INR is within the therapeutic range, after which patients will be asked for monthly follow-up INR reports. The patients in the control group will not be treated with heparin or low molecular weight heparin before the INR is maintained in the therapeutic range.

Warfarin

Eligibility Criteria

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

You may qualify if:

• Patients aged \>18 years hospitalized with the diagnosis of acute STEMI and
• Presence of LV thrombus which is confirmed with cardiac MRI.

You may not qualify if:

• Bleeding risk Active bleeding; history of intracranial hemorrhage; clinically significant gastrointestinal bleeding within 12 months before randomization; severe thrombocytopenia (\<50×109/L), or anemia (i.e., hemoglobin \<90 g/L) at screening or pre-randomization; Liver function Child-Pugh B or C; untreated arterial aneurysm, arterial or venous malformation and aorta dissection; and body weight \<40 kg.
• Undergoing anticoagulation therapy
• Cardiovascular condition Cardiac shock; uncontrolled blood pressure (SBP ≥180 mmHg); planned CABG within 3 months; suspicious Pseudo-ventricular aneurysm
• Concomitant diseases Severe chronic or acute renal failure (CrCl \<50 mL/min at screening or pre-randomization); significant liver disease; current substance abuse (drug or alcohol) problem; life expectancy to less than 12 months; Known allergies, or intolerance to rivaroxaban; Woman who is currently pregnant, or breastfeeding; and Other hypercoagulable states, such as a malignant tumor, SLE
• Other conditions adjudicated by investigators to be unsuitable for anticoagulation
• Pregnant women and participants with any cognitive impairment.

Sponsors & Collaborators

• Shahid Gangalal National Heart Centre: lead

Study Sites (1)

Nepal Health Research Council

Kathmandu, Bagmati, Nepal

RECRUITING

Related Publications (15)

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  BACKGROUND

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  BACKGROUND

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MeSH Terms

Conditions

Myocardial Infarction

Interventions

Rivaroxaban; Warfarin

Condition Hierarchy (Ancestors)

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; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Dipanker Prajapati, MBBS, MD

CONTACT

9849273202; dpcardio@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The radiologist who will assess the presence or absence of left ventricular (LV) thrombus will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Cardiologist

Model Details: 1:1 parallel study design

Study Record Dates

• First Submitted: March 20, 2023
• First Posted: April 3, 2023
• Study Start: June 19, 2023
• Primary Completion: March 1, 2026
• Study Completion: April 1, 2026
• Last Updated: May 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)