Left Ventricular ThrombusPhase 4WaRMINNCT05794399
Anticoagulation in Post MI LV Thrombus Trial in Nepal
A Phase 4 study testing Rivaroxaban and Warfarin in people with Left Ventricular Thrombus and Myocardial Infarction, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Left Ventricular Thrombus, Myocardial Infarction
- What is being tested?
- Rivaroxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 1 siteNepal
- Study dates
- 19 Jun 2023to Apr 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged >18 years hospitalized with the diagnosis of acute STEMI and
- Presence of LV thrombus which is confirmed with cardiac MRI.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site, 1 recruiting
- Recruiting
Nepal Health Research Council
Kathmandu, Bagmati
NHRC, 977-1-4254220, nhrc@nhrc.gov.np
About this study
Official title: 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.
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.
Read more
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.
Read the detailed description
Cardiovascular disease is the leading cause of mortality and morbidity among non-communicable diseases worldwide including in Nepal. Myocardial infarction(MI) is the main disease among cardiovascular diseases. [i] MI is also the main reason for hospitalization in the cardiac centers of our country. [ii] There is an additional burden of late presentation of MI in our setting due to lack of proper awareness, limited access to health care and improper referral mechanism. In the hospital-based registry in 2018, more than 65% of acute MI presented after the eligible time frame for primary angioplasty or thrombolysis. [iii] The incidence of the formation of left ventricular (LV) thrombus is increased with the late presentation. Worldwide, the prevalence of LV thrombus before the era of primary angioplasty was around 31-57%. [iv],[v],[vi] After the start of the primary angioplasty techniques, the prevalence of post-MI LV thrombus has decreased to around 15%.[vii] However, it is still associated with increased risks of embolic events and mortality.[viii],[ix],[x] European and American guidelines have recommended using vitamin K antagonist (VKA) for a minimum of 3-6 months as a class IIa, LOE c, with duration individualized to bleeding risk with a target of international normalized ratio (INR) of 2.5 (range of 2 to 3). [xi],[xii] Non-VKA oral anticoagulants (NOACs) in addition to the dual antiplatelet therapy in these patients are attractive alternatives because of their potential efficacy and safety along with ease of administration, lack of requirement for INR monitoring or dietary restrictions resulting in overall improvement of life.[xiii] However, there is no randomized control trial comparing warfarin and NOACs. There are two ongoing trials NCT01556659 and NCT03764241. The recommendation is more relevant to us as there is an overburden of patients presenting late due to various geographical and financial reasons. This study was designed for the evaluation of anticoagulation effects among the acute ST elevation Myocardial Infarction (STEMI) with LV thrombus in complete resolution of LV thrombus. The investigators aim to compare Warfarin to Rivaroxaban in the management of post-myocardial infarction left ventricular thrombus in our part of the world.
Data management and Analysis Plan:
Independent data safety and monitoring board will be formed and will be responsible for the safety concerns of the research participants. Data will be collected and entered in the computer-based CRF constructed using the password-protected free software at https://www.kobotoolbox.org. The data will be accessed by the principal investigator and the research officer only. The data will be anonymized before statistical analysis which will be performed by the separate coinvestigators responsible for the data analysis. Appropriate statistical tests will be used for measuring association and correlation. A 'P' value of less than 0.05 will be considered to be significant.
Dissemination Plan:
The findings of the study will be published in a peer-reviewed journal and presented at national and international conferences.
- Conditions
- Left Ventricular Thrombus, Myocardial Infarction
- Being tested
- Rivaroxaban, Warfarin
- Keywords
- Post Myocardial Infarction, Left Ventricular Thrombus, Warfarin, Rivaroxaban, Nepal
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
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.
WarfarinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
LV thrombus resolution
The primary endpoint will be a resolution of LV thrombus as assessed by cardiac MRI in 3 months of study.
Measured: 3 months
Secondary outcomes (2)
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
- Fatal bleeding. and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome. and/or
- 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.
Measured: 3 months
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]
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start19 Jun 2023
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Left Ventricular ThrombusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 parallel study design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Gangalal National Heart Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dipanker Prajapati, Shahid Gangalal National Heart Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05794399
- Sponsor's protocol ID
- SGNHC-RCT
- Acronym
- WaRMIN
- Status last verified
- May 2025
- First submitted
- 20 Mar 2023
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data safety and monitoring board will be formed which will be responsible for safety supervision and monitoring among our study participants. The board will include three members each from the Department of Cardiology, the Department of Cardiac Surgery and the Department of Cardiac Anesthesia. The board will be responsible for the safety of the study participants. The principal investigator will be primarily responsible for the entire research. A well-trained research officer will be hired who will be responsible for the recruitment of the participants, obtaining consent forms and informing the principal investigator regarding the allocation of the treatment group. The principal investigator along with the coinvestigators will be primarily responsible for the treatment of the patients and drug dosage escalation/de-escalation according to the INR report. The quality of the data will be ensured by regular data monitoring by the principal investigator.
Publications
Bhattarai S, Aryal A, Pyakurel M, Bajracharya S, Baral P, Citrin D, Cox H, Dhimal M, Fitzpatrick A, Jha AK, Jha N, Karmacharya BM, Koju R, Maharjan R, Oli N, Pyakurel P, Sapkota BP, Shrestha R, Shrestha S, Spiegelman D, Vaidya A, Shrestha A. Cardiovascular disease trends in Nepal - An analysis of global burden of disease data 2017. Int J Cardiol Heart Vasc. 2020 Jul 31;30:100602. doi: 10.1016/j.ijcha.2020.100602. eCollection 2020 Oct.
PubMed 32775605Adhikari, C. M., Acharya, K. P., Manandhar, R., Sherpa, K., Tamrakar, R., Bogati, A., Singh, S. K., Kansakar, S., Yadav, D. N., Dhungana, M., Dhungel, S., Baniya, B., Joshi, S., Rajbhandari, S., Pandey, R., Raut, R., Prajapati, D., KC, S. S., Adhikari, J., Adhikari, A., Gautam, B., Najmy, S., Poudel, R., Timalsina, B. K., Karki, P., Poudel, S., Thakur, K. K., Limbu, D., Nepal, H. P., Sharma, M., Rauniyar, B. K., Rajbhandari, R., Limbu, Y. R., Maskey, A., Malla, R., Sharma, D., & KC, M. B. (2020). Shahid Gangalal National Heart Centre-ST-elevation Myocardial infarction Registry (SGNHC-STEMI-Registry), Nepal. Nepalese Heart Journal, 17(1), 7-16. https://doi.org/10.3126/njh.v17i1.28795
Gottdiener JS, Gay JA, VanVoorhees L, DiBianco R, Fletcher RD. Frequency and embolic potential of left ventricular thrombus in dilated cardiomyopathy: assessment by 2-dimensional echocardiography. Am J Cardiol. 1983 Dec 1;52(10):1281-5. doi: 10.1016/0002-9149(83)90588-x.
PubMed 6650417Gottdiener JS, Massie B, Ammons SB, et al. Prevalence of left ventricular thrombus in dilated cardiomyopathy: the WATCH trial. J Am J Cardiol 2003;41:202.
Srichai MB, Junor C, Rodriguez LL, Stillman AE, Grimm RA, Lieber ML, Weaver JA, Smedira NG, White RD. Clinical, 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. Am Heart J. 2006 Jul;152(1):75-84. doi: 10.1016/j.ahj.2005.08.021.
PubMed 16824834Keeley EC, Hillis LD. Left ventricular mural thrombus after acute myocardial infarction. Clin Cardiol. 1996 Feb;19(2):83-6. doi: 10.1002/clc.4960190203.
PubMed 8821415Pizzetti G, Belotti G, Margonato A, Carlino M, Gerosa S, Carandente O, Chierchia SL. Thrombolytic therapy reduces the incidence of left ventricular thrombus after anterior myocardial infarction. Relationship to vessel patency and infarct size. Eur Heart J. 1996 Mar;17(3):421-8. doi: 10.1093/oxfordjournals.eurheartj.a014875.
PubMed 8737217Bhatnagar SK, al-Yusuf AR. Effects 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. Am Heart J. 1991 Nov;122(5):1251-6. doi: 10.1016/0002-8703(91)90563-w.
PubMed 1659166Ezekowitz MD, Wilson DA, Smith EO, Burow RD, Harrison LH Jr, Parker DE, Elkins RC, Peyton M, Taylor FB. Comparison of Indium-111 platelet scintigraphy and two-dimensional echocardiography in the diagnosis of left ventricular thrombi. N Engl J Med. 1982 Jun 24;306(25):1509-13. doi: 10.1056/NEJM198206243062502.
PubMed 7078607Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 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). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
PubMed 28886621O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 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. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
PubMed 23256914Keita I, Aubin-Auger I, Lalanne C, Aubert JP, Chassany O, Duracinsky M, Mahe I. Assessment 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. Patient Prefer Adherence. 2017 Sep 25;11:1625-1634. doi: 10.2147/PPA.S131157. eCollection 2017.
PubMed 29026288Schulman S, Kearon C; Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost. 2005 Apr;3(4):692-4. doi: 10.1111/j.1538-7836.2005.01204.x.
PubMed 15842354Kleindorfer DO, Towfighi A, Chaturvedi S, Cockroft KM, Gutierrez J, Lombardi-Hill D, Kamel H, Kernan WN, Kittner SJ, Leira EC, Lennon O, Meschia JF, Nguyen TN, Pollak PM, Santangeli P, Sharrief AZ, Smith SC Jr, Turan TN, Williams LS. 2021 Guideline for the Prevention of Stroke in Patients With Stroke and Transient Ischemic Attack: A Guideline From the American Heart Association/American Stroke Association. Stroke. 2021 Jul;52(7):e364-e467. doi: 10.1161/STR.0000000000000375. Epub 2021 May 24. No abstract available.
PubMed 34024117Saleh Y, Al-Abcha A, Abdelkarim O, Elwany M, Abdelfattah OM, Abdelnabi M, Almaghraby A. Meta-Analysis Comparing the Effect of Rivaroxaban Versus Vitamin K Antagonists for Treatment of Left Ventricular Thrombi. Am J Cardiol. 2021 Dec 15;161:123-125. doi: 10.1016/j.amjcard.2021.09.009. Epub 2021 Oct 14. No abstract available.
PubMed 34656296
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05794399
- Acronym / sponsor ID
- WaRMIN / SGNHC-RCT
- Conditions
- Left Ventricular Thrombus, Myocardial Infarction
- Keywords
- Post Myocardial Infarction, Left Ventricular Thrombus, Warfarin, Rivaroxaban, Nepal
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Shahid Gangalal National Heart CentreUniversity, hospital or other
- Study start
- 19 Jun 2023 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 3 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cardiovascular disease is the leading cause of mortality and morbidity among non-communicable diseases worldwide including in Nepal. Myocardial infarction(MI) is the main disease among cardiovascular diseases. [i] MI is also the main reason for hospitalization in the cardiac centers of our country. [ii] There is an additional burden of late presentation of MI in our setting due to lack of proper awareness, limited access to health care and improper referral mechanism. In the hospital-based registry in 2018, more than 65% of acute MI presented after the eligible time frame for primary angioplasty or thrombolysis. [iii] The incidence of the formation of left ventricular (LV) thrombus is increased with the late presentation. Worldwide, the prevalence of LV thrombus before the era of primary angioplasty was around 31-57%. [iv],[v],[vi] After the start of the primary angioplasty techniques, the prevalence of post-MI LV thrombus has decreased to around 15%.[vii] However, it is still associated with increased risks of embolic events and mortality.[viii],[ix],[x] European and American guidelines have recommended using vitamin K antagonist (VKA) for a minimum of 3-6 months as a class IIa, LOE c, with duration individualized to bleeding risk with a target of international normalized ratio (INR) of 2.5 (range of 2 to 3). [xi],[xii] Non-VKA oral anticoagulants (NOACs) in addition to the dual antiplatelet therapy in these patients are attractive alternatives because of their potential efficacy and safety along with ease of administration, lack of requirement for INR monitoring or dietary restrictions resulting in overall improvement of life.[xiii] However, there is no randomized control trial comparing warfarin and NOACs. There are two ongoing trials NCT01556659 and NCT03764241. The recommendation is more relevant to us as there is an overburden of patients presenting late due to various geographical and financial reasons. This study was designed for the evaluation of anticoagulation effects among the acute ST elevation Myocardial Infarction (STEMI) with LV thrombus in complete resolution of LV thrombus. The investigators aim to compare Warfarin to Rivaroxaban in the management of post-myocardial infarction left ventricular thrombus in our part of the world.
Data management and Analysis Plan:
Independent data safety and monitoring board will be formed and will be responsible for the safety concerns of the research participants. Data will be collected and entered in the computer-based CRF constructed using the password-protected free software at https://www.kobotoolbox.org. The data will be accessed by the principal investigator and the research officer only. The data will be anonymized before statistical analysis which will be performed by the separate coinvestigators responsible for the data analysis. Appropriate statistical tests will be used for measuring association and correlation. A 'P' value of less than 0.05 will be considered to be significant.
Dissemination Plan:
The findings of the study will be published in a peer-reviewed journal and presented at national and international conferences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 1:1 parallel study design
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban | Experimental | Drug: RivaroxabanIn this arm, the patients with post-myocardial infarction and left ventricular thrombus will be treated with Rivaroxaban 20mg or 15mg as indicated. |
| Warfarin | Active comparator | Drug: WarfarinIn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged >18 years hospitalized with the diagnosis of acute STEMI and
- Presence of LV thrombus which is confirmed with cardiac MRI.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivaroxabanIntervention 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. | Drug | Rivaroxaban |
| WarfarinControl 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. | Drug | Warfarin |
Primary outcome
LV thrombus resolution
Time frame: 3 months
The primary endpoint will be a resolution of LV thrombus as assessed by cardiac MRI in 3 months of study.
2 secondary outcomes
Major bleeding events
Time frame: 3 months
Embolic events
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Background: PubMed 32775605Bhattarai S, Aryal A, Pyakurel M, Bajracharya S, Baral P, Citrin D, Cox H, Dhimal M, Fitzpatrick A, Jha AK, Jha N, Karmacharya BM, Koju R, Maharjan R, Oli N, Pyakurel P, Sapkota BP, Shrestha R, Shrestha S, Spiegelman D, Vaidya A, Shrestha A. Cardiovascular disease trends in Nepal - An analysis of global burden of disease data 2017. Int J Cardiol Heart Vasc. 2020 Jul 31;30:100602. doi: 10.1016/j.ijcha.2020.100602. eCollection 2020 Oct.
- BackgroundAdhikari, C. M., Acharya, K. P., Manandhar, R., Sherpa, K., Tamrakar, R., Bogati, A., Singh, S. K., Kansakar, S., Yadav, D. N., Dhungana, M., Dhungel, S., Baniya, B., Joshi, S., Rajbhandari, S., Pandey, R., Raut, R., Prajapati, D., KC, S. S., Adhikari, J., Adhikari, A., Gautam, B., Najmy, S., Poudel, R., Timalsina, B. K., Karki, P., Poudel, S., Thakur, K. K., Limbu, D., Nepal, H. P., Sharma, M., Rauniyar, B. K., Rajbhandari, R., Limbu, Y. R., Maskey, A., Malla, R., Sharma, D., & KC, M. B. (2020). Shahid Gangalal National Heart Centre-ST-elevation Myocardial infarction Registry (SGNHC-STEMI-Registry), Nepal. Nepalese Heart Journal, 17(1), 7-16. https://doi.org/10.3126/njh.v17i1.28795
- Background: PubMed 6650417Gottdiener JS, Gay JA, VanVoorhees L, DiBianco R, Fletcher RD. Frequency and embolic potential of left ventricular thrombus in dilated cardiomyopathy: assessment by 2-dimensional echocardiography. Am J Cardiol. 1983 Dec 1;52(10):1281-5. doi: 10.1016/0002-9149(83)90588-x.
- BackgroundGottdiener JS, Massie B, Ammons SB, et al. Prevalence of left ventricular thrombus in dilated cardiomyopathy: the WATCH trial. J Am J Cardiol 2003;41:202.
- Background: PubMed 16824834Srichai MB, Junor C, Rodriguez LL, Stillman AE, Grimm RA, Lieber ML, Weaver JA, Smedira NG, White RD. Clinical, 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. Am Heart J. 2006 Jul;152(1):75-84. doi: 10.1016/j.ahj.2005.08.021.
- Background: PubMed 8821415Keeley EC, Hillis LD. Left ventricular mural thrombus after acute myocardial infarction. Clin Cardiol. 1996 Feb;19(2):83-6. doi: 10.1002/clc.4960190203.
- Background: PubMed 8737217Pizzetti G, Belotti G, Margonato A, Carlino M, Gerosa S, Carandente O, Chierchia SL. Thrombolytic therapy reduces the incidence of left ventricular thrombus after anterior myocardial infarction. Relationship to vessel patency and infarct size. Eur Heart J. 1996 Mar;17(3):421-8. doi: 10.1093/oxfordjournals.eurheartj.a014875.
- Background: PubMed 1659166Bhatnagar SK, al-Yusuf AR. Effects 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. Am Heart J. 1991 Nov;122(5):1251-6. doi: 10.1016/0002-8703(91)90563-w.
- Background: PubMed 7078607Ezekowitz MD, Wilson DA, Smith EO, Burow RD, Harrison LH Jr, Parker DE, Elkins RC, Peyton M, Taylor FB. Comparison of Indium-111 platelet scintigraphy and two-dimensional echocardiography in the diagnosis of left ventricular thrombi. N Engl J Med. 1982 Jun 24;306(25):1509-13. doi: 10.1056/NEJM198206243062502.
- Background: PubMed 28886621Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 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). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.
- Background: PubMed 23256914O'Gara PT, Kushner FG, Ascheim DD, Casey DE Jr, Chung MK, de Lemos JA, Ettinger SM, Fang JC, Fesmire FM, Franklin BA, Granger CB, Krumholz HM, Linderbaum JA, Morrow DA, Newby LK, Ornato JP, Ou N, Radford MJ, Tamis-Holland JE, Tommaso CL, Tracy CM, Woo YJ, Zhao DX. 2013 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. J Am Coll Cardiol. 2013 Jan 29;61(4):e78-e140. doi: 10.1016/j.jacc.2012.11.019. Epub 2012 Dec 17. No abstract available.
- Background: PubMed 29026288Keita I, Aubin-Auger I, Lalanne C, Aubert JP, Chassany O, Duracinsky M, Mahe I. Assessment 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. Patient Prefer Adherence. 2017 Sep 25;11:1625-1634. doi: 10.2147/PPA.S131157. eCollection 2017.
- Individual participant dataSharing planned: No. The data safety and monitoring board will be formed which will be responsible for safety supervision and monitoring among our study participants. The board will include three members each from the Department of Cardiology, the Department of Cardiac Surgery and the Department of Cardiac Anesthesia. The board will be responsible for the safety of the study participants. The principal investigator will be primarily responsible for the entire research. A well-trained research officer will be hired who will be responsible for the recruitment of the participants, obtaining consent forms and informing the principal investigator regarding the allocation of the treatment group. The principal investigator along with the coinvestigators will be primarily responsible for the treatment of the patients and drug dosage escalation/de-escalation according to the INR report. The quality of the data will be ensured by regular data monitoring by the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban and Warfarin in people with Left Ventricular Thrombus and Myocardial Infarction, run by Shahid Gangalal National Heart Centre at 1 site in Nepal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nepal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dipanker Prajapati, MBBS, MD (9849273202 ext. 977, dpcardio@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LV thrombus resolution (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05794399, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.