Anticoagulation in Post MI LV Thrombus Trial in Nepal
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorShahid Gangalal National Heart Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged >18 years hospitalized with the diagnosis of acute STEMI and
Presence of LV thrombus which is confirmed with cardiac MRI.
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Rivaroxaban
DrugIntervention 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.
Warfarin
DrugControl 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.
Treatment groups
196 Participants
are divided into 2 treatment groupsGroup A: RivaroxabanExperimental treatment 1 intervention
Group B: WarfarinActive comparator 1 intervention
Trial outcomes
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.
Time frame
3 monthsSecondary outcomes
1
Major bleeding events
The major bleeding events will be defined according to the definition of major bleeding for non-surgical patients according to the International Society on Thrombosis and Haemostasis (ISTH)/Scientific and Standardization Committee (SSC)\[xiv\] which is 1. Fatal bleeding. and/or 2. Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or 3. Bleeding causing a fall in hemoglobin level of 2 g/dL (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
Time frame
3 months2
Embolic events
Embolic events will be defined as Cardioembolic stroke that is stroke attributable to arterial occlusion from an embolus that presumably arose in the heart. Ischemic stroke in the vascular distribution of a major intracranial or extracranial artery with \>50% stenosis or occlusion on vascular imaging. Clinical findings include those of cerebral cortical involvement or brainstem or cerebellar dysfunction. Cortical and cerebellar lesions and brainstem or subcortical lesions \>1.5 cm are considered potentially caused by large artery atherosclerosis. Evidence of a previous TIA or stroke in \>1 vascular territory supports a clinical diagnosis of cardioembolic stroke.\[xv\]
Time frame
3 monthsSponsors and contacts
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Source ClinicalTrials.gov