Cardiovascular disease trends in Nepal - An analysis of global burden of disease data 2017.
Sanju Bhattarai, Anu Aryal, Manita Pyakurel...
https://pubmed.ncbi.nlm.nih.gov/32775605Actively Recruiting
Phase 4
Age: 18Years +
All Genders
ID05794399
Comparison of Warfarin Versus Rivaroxaban in Management of Post-myocardial Infarction Left Ventricular Thrombus in a Tertiary Cardiac Center of Nepal: a Randomized Control Study
Led by Shahid Gangalal National Heart Centre · Updated on 2025-05-11
196
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to compare the effects of two blood-thinning medications, rivaroxaban and warfarin, in patients who develop a blood clot in the left ventricle of the heart after a heart attack. The study focuses on people who had a delayed hospital visit after their heart attack, a common issue in some regions, which increases the risk of such clots and related complications. The goal is to find out which medication better helps dissolve the clot and is safer to use. Participants will be randomly assigned to receive either rivaroxaban or warfarin. Those in the rivaroxaban group will take 15 to 20 mg doses depending on kidney function once daily with an evening meal. The warfarin group will start at 5 mg daily, adjusted to keep blood clotting levels within a target range, monitored by regular blood tests called INR. The study will last for three months, with follow-up visits scheduled to monitor treatment effects and any side effects. During the study, participants will undergo cardiac MRI scans to check if the blood clot has resolved after three months. Researchers will also monitor for major bleeding events and any embolic complications. Data will be securely collected and analyzed to assess the safety and effectiveness of both treatments. The study includes safety oversight by an independent board and plans to share findings through scientific publications and conferences.
CONDITIONS
Brief Title
Anticoagulation in Post MI LV Thrombus Trial in Nepal
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients aged over 18 years hospitalized with acute STEMI
- Presence of left ventricular thrombus confirmed by cardiac MRI
You will not qualify if you...
- Active bleeding or history of significant bleeding within the past 12 months
- Severe thrombocytopenia or anemia at screening
- Liver impairment classified as Child-Pugh B or C
- Untreated arterial aneurysm, arterial or venous malformations, or aortic dissection
- Body weight less than 40 kg
- Currently receiving anticoagulation therapy
- Cardiac shock or uncontrolled high blood pressure (systolic BP ≥180 mmHg)
- Planned coronary artery bypass surgery within 3 months
- Suspicion of pseudo-ventricular aneurysm
- Severe chronic or acute kidney failure (creatinine clearance <50 mL/min)
- Significant liver disease
- Current drug or alcohol abuse
- Life expectancy less than 12 months
- Known allergy or intolerance to rivaroxaban
- Pregnant or breastfeeding women
- Other hypercoagulable conditions such as malignant tumors or systemic lupus erythematosus
- Cognitive impairment or other conditions deemed unsuitable for anticoagulation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 months
Participants receive anticoagulation treatment with either Rivaroxaban or Warfarin to manage post-myocardial infarction left ventricular thrombus.
Follow-up visits scheduled after 3 months or as needed if bleeding symptoms occur; Warfarin group has frequent INR monitoring visits initially, then monthly visits
Trial Site Locations
Total: 1 location
1
Nepal Health Research Council
Kathmandu, Bagmati, Nepal
Actively Recruiting
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Research Team
D
Dipanker Prajapati, MBBS, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Frequency and embolic potential of left ventricular thrombus in dilated cardiomyopathy: assessment by 2-dimensional echocardiography.
J S Gottdiener, J A Gay, L VanVoorhees...
https://pubmed.ncbi.nlm.nih.gov/6650417Clinical, imaging, and pathological characteristics of left ventricular thrombus: a comparison of contrast-enhanced magnetic resonance imaging, transthoracic echocardiography, and transesophageal echocardiography with surgical or pathological validation.
Monvadi B Srichai, Chelif Junor, L Leonardo Rodriguez...
https://pubmed.ncbi.nlm.nih.gov/16824834Left ventricular mural thrombus after acute myocardial infarction.
E C Keeley, L D Hillis
https://pubmed.ncbi.nlm.nih.gov/8821415Thrombolytic therapy reduces the incidence of left ventricular thrombus after anterior myocardial infarction. Relationship to vessel patency and infarct size.
G Pizzetti, G Belotti, A Margonato...
https://pubmed.ncbi.nlm.nih.gov/8737217Effects of intravenous recombinant tissue-type plasminogen activator therapy on the incidence and associations of left ventricular thrombus in patients with a first acute Q wave anterior myocardial infarction.
S K Bhatnagar, A R al-Yusuf
https://pubmed.ncbi.nlm.nih.gov/1659166Comparison of Indium-111 platelet scintigraphy and two-dimensional echocardiography in the diagnosis of left ventricular thrombi.
M D Ezekowitz, D A Wilson, E O Smith...
https://pubmed.ncbi.nlm.nih.gov/70786072017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC).
Borja Ibanez, Stefan James, Stefan Agewall...
https://pubmed.ncbi.nlm.nih.gov/288866212013 ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.
Patrick T O'Gara, Frederick G Kushner, Deborah D Ascheim...
https://pubmed.ncbi.nlm.nih.gov/23256914Assessment of quality of life, satisfaction with anticoagulation therapy, and adherence to treatment in patients receiving long-course vitamin K antagonists or direct oral anticoagulants for venous thromboembolism.
Ingre Keita, Isabelle Aubin-Auger, Christophe Lalanne...
https://pubmed.ncbi.nlm.nih.gov/29026288