Acute Coronary SyndromePhase 4NCT04970576
Rivaroxaban in Left Ventricular Thrombus
A Phase 4 study testing Rivaroxaban and Warfarin in people with Acute Coronary Syndrome and Left Ventricular Thrombus, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
Trial summary
The left ventricular (LV) thrombus is an important complication of myocardial infarction (MI) and vitamin K antagonist (VKA) is the current recommended management therapy for these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Left Ventricular Thrombus
- What is being tested?
- Rivaroxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 261 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Jun 2021to 31 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 of acute coronary syndrome with LV thrombus
- Hemodynamically stable
- Willing to participate
Who cannot join
- Prior history of cardiomyopathy
- Anticoagulant contraindications
- Prior history of stroke with residual neurological deficit
- Valvular atrial fibrilation
- Pregnancy
- Mentally retarded
- Deranged liver function tests (LFTS)
- Creatinine Clearance <50 ml
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75510
About this study
Official title: Efficacy of Rivaroxaban in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: An Open Label Randomized Control Trial
The left ventricular (LV) thrombus is an important complication of myocardial infarction (MI) and vitamin K antagonist (VKA) is the current recommended management therapy for these patients. However, lack of regular international normalized ratio (INR) monitoring, drug, and food interaction may leads to increased risk of over or under anticoagulation consequently compromising the effectiveness of the therapy. Hence, due to benefits like predictable dosing and lack of need for regular monitoring, use of non-vitamin K antagonist oral anticoagulants (NOACs) for these patients is increasing among cardiologists. However, clinical data for the justified use of NOACs in LV thrombus (LVT) are lacking and remained a point of debate among the cardiologists. A recently published Randomized Control Trial (RCT) by Abdelnabi M et al. namely the No-LVT trial, had established the safety of Rivaroxaban therapy in patient with post myocardial infarction (MI) LV thrombus along with promising efficacy. However, sample size of the study (n=79; 39 in Rivaroxaban and 40 Warfarin) was not sufficiently high enough to conclude efficacy of Rivaroxaban in these patients. Therefore, this open label RCT is designed with the primary objective to evaluate the efficacy of Rivaroxaban in resolution of post MI LV thrombus as compared to standard warfarin therapy at the interval of 1 month and 3 months to test the hypothesis that Rivaroxaban is safe and non-inferior in preventing thromboembolic and major bleeding events in these patients.
- Conditions
- Acute Coronary Syndrome, Left Ventricular Thrombus
- Being tested
- Rivaroxaban, Warfarin
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Dose of 20 mg once a day for three months followed by transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks
WarfarinDrug
Dose as per the target INR of 2 to 3 with transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Patients in the intervention group will receive Rivaroxaban 20 mg once a day (OD) for three months Receives: Drug: Rivaroxaban |
| Control group | Active comparator | Patients in the control group will receive usual warfarin therapy dose adjusted as per the target INR of 2 to 3 Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular (LV) thrombus
Presence or absence of LV thrombus on transthoracic echocardiographic
Measured: After 12 weeks of randomization
Secondary outcomes (2)
Stroke or systemic embolism
Confirmed on computerized tomography (CT) scan
Measured: Within 12 weeks of randomization
Major bleeding
As per the International Society on Thrombosis and Haemostasis (ISTH) criteria
Measured: Within 12 weeks of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2021
- Study start25 Jun 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Cardiovascular Diseases, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jehangir Ali Shah, National Institute of Cardiovascular Diseases, Pakistan
- Investigators
- Jehangir A Shah, FCPS, Principal investigator, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04970576
- Sponsor's protocol ID
- ERC-70/2021
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2021
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdelnabi M, Saleh Y, Fareed A, Nossikof A, Wang L, Morsi M, Eshak N, Abdelkarim O, Badran H, Almaghraby A. Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT Trial). J Am Coll Cardiol. 2021 Mar 30;77(12):1590-1592. doi: 10.1016/j.jacc.2021.01.049. No abstract available.
PubMed 33766266Shah JA, Hussain J, Ahmed B, Batra MK, Ali G, Naz M, Khan W, Bhatti KI, Karim M, Hakeem A. Rivaroxaban vs Warfarin in Acute Left Ventricular Thrombus Following Myocardial Infarction: RIVAWAR, An Open-Label RCT. JACC Adv. 2025 Aug;4(8):101978. doi: 10.1016/j.jacadv.2025.101978. Epub 2025 Jul 23.
PubMed 40706143
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Rivaroxaban in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: An Open Label Randomized Control Trial
- ClinicalTrials.gov ID
- NCT04970576
- Acronym / sponsor ID
- ERC-70/2021
- Conditions
- Acute Coronary Syndrome, Left Ventricular Thrombus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- National Institute of Cardiovascular Diseases, PakistanUniversity, hospital or other
- Study start
- 25 Jun 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 21 Jul 2021 (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.
The left ventricular (LV) thrombus is an important complication of myocardial infarction (MI) and vitamin K antagonist (VKA) is the current recommended management therapy for these patients. However, lack of regular international normalized ratio (INR) monitoring, drug, and food interaction may leads to increased risk of over or under anticoagulation consequently compromising the effectiveness of the therapy. Hence, due to benefits like predictable dosing and lack of need for regular monitoring, use of non-vitamin K antagonist oral anticoagulants (NOACs) for these patients is increasing among cardiologists. However, clinical data for the justified use of NOACs in LV thrombus (LVT) are lacking and remained a point of debate among the cardiologists. A recently published Randomized Control Trial (RCT) by Abdelnabi M et al. namely the No-LVT trial, had established the safety of Rivaroxaban therapy in patient with post myocardial infarction (MI) LV thrombus along with promising efficacy. However, sample size of the study (n=79; 39 in Rivaroxaban and 40 Warfarin) was not sufficiently high enough to conclude efficacy of Rivaroxaban in these patients. Therefore, this open label RCT is designed with the primary objective to evaluate the efficacy of Rivaroxaban in resolution of post MI LV thrombus as compared to standard warfarin therapy at the interval of 1 month and 3 months to test the hypothesis that Rivaroxaban is safe and non-inferior in preventing thromboembolic and major bleeding events in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: RivaroxabanPatients in the intervention group will receive Rivaroxaban 20 mg once a day (OD) for three months |
| Control group | Active comparator | Drug: WarfarinPatients in the control group will receive usual warfarin therapy dose adjusted as per the target INR of 2 to 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients of acute coronary syndrome with LV thrombus
- Hemodynamically stable
- Willing to participate
Key exclusion criteria (8 listed)
- Prior history of cardiomyopathy
- Anticoagulant contraindications
- Prior history of stroke with residual neurological deficit
- Valvular atrial fibrilation
- Pregnancy
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 |
|---|---|---|
| RivaroxabanDose of 20 mg once a day for three months followed by transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks | Drug | Treatment group |
| WarfarinDose as per the target INR of 2 to 3 with transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks | Drug | Control group |
Primary outcome
Left ventricular (LV) thrombus
Time frame: After 12 weeks of randomization
Presence or absence of LV thrombus on transthoracic echocardiographic
2 secondary outcomes
Stroke or systemic embolism
Time frame: Within 12 weeks of randomization
Major bleeding
Time frame: Within 12 weeks of randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Results publication: PubMed 33766266Abdelnabi M, Saleh Y, Fareed A, Nossikof A, Wang L, Morsi M, Eshak N, Abdelkarim O, Badran H, Almaghraby A. Comparative Study of Oral Anticoagulation in Left Ventricular Thrombi (No-LVT Trial). J Am Coll Cardiol. 2021 Mar 30;77(12):1590-1592. doi: 10.1016/j.jacc.2021.01.049. No abstract available.
- Derived from this study: PubMed 40706143Shah JA, Hussain J, Ahmed B, Batra MK, Ali G, Naz M, Khan W, Bhatti KI, Karim M, Hakeem A. Rivaroxaban vs Warfarin in Acute Left Ventricular Thrombus Following Myocardial Infarction: RIVAWAR, An Open-Label RCT. JACC Adv. 2025 Aug;4(8):101978. doi: 10.1016/j.jacadv.2025.101978. Epub 2025 Jul 23.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Jehangir A Shah, FCPS principal investigator
National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
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 Acute Coronary Syndrome and Left Ventricular Thrombus, run by National Institute of Cardiovascular Diseases, Pakistan at 1 site in Pakistan.
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 3 inclusion and 8 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: finished, as of the sponsor's last update on 15 Nov 2024. 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular (LV) thrombus (time frame: After 12 weeks of randomization). 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 NCT04970576, which also lists 2 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 15 Nov 2024.