Protocol summary
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Study aim
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Comparison of the safety of rivaroxaban-based versus warfarin-based antithrombotic regimens in patients with acute ST elevation myocardial infarction left ventricular thrombosis
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Design
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Two parallel groups randomized trial with blinded outcome assessment
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Settings and conduct
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The trial will take place in hospital setting (Rajaie cardiovascular medical and research center along with Tehran heart center) on patients with acute STEMI complicated by LVT. Patients will be randomized via central web based method into two interventional groups with two different antithrombotic regimen. Treating physician and patients will not be blinded. Thrombus status (assessed via echocardiography) and bleeding complications will be evaluated after 1 and 3 months.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1. All patients with the age of 18-80 admitted with an acute STEMI
2. Presence of left ventricular thrombosis, confirmed by transthoracic echocardiography
3. Signed informed consent
Exclusion criteria:
1. Previous history of mechanical prosthetic heart valve
2. Candidate for coronary artery bypass graft surgery
3. Active bleeding
4. Cardiogenic shock
5. Acute kidney injury or chronic kidney disease with a GFR<30 ml/min
6.Liver failure(Child-Pugh class C)
7.Sensitivity or intolerance with rivaroxaban/warfarin
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Intervention groups
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The study contains two groups:
- Intervention: rivaroxaban (15 mg daily, oral) plus clopidogrel (75 mg daily, oral) plus ASA (80 mg daily, oral; only during the first 7 days)
- Control: warfarin (target INR of 2.0-3.0) plus clopidogrel(75 mg daily, oral) plus ASA (80 mg daily, oral; only during the first 7 days)
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Main outcome variables
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LVT resolution; LVT size; thromboembolic events; all-cause death; bleeding
General information
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Reason for update
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There were few cases limited to acute STEMI who have undergone PCI. Consequently we have expanded our inclusion criteria to all patients complicating with acute STEMI
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20181022041406N4
Registration date:
2020-07-30, 1399/05/09
Registration timing:
registered_while_recruiting
Last update:
2021-08-09, 1400/05/18
Update count:
1
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Registration date
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2020-07-30, 1399/05/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2022-06-22, 1401/04/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Rivaroxaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: A Randomized Controlled Pilot Trial
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Public title
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Rivaroxaban in Left Ventricular Thrombus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
All patients with the age of 18-80 admitted with an acute STEMI
Presence of LV thrombosis, which were confirmed by transthrocic echocardiography
Signed informed consent
Exclusion criteria:
Previous history of mechanical prosthetic heart valve
Candidate for coronary artery bypass graft surgery
Active bleeding
Cardiogenic shock
Acute Kidney Injury or Chronic Kidney Disease with a glomerular filtration rate <30 ml/min
Liver failure (Child-Pugh class C)
Sensitivity or intolerance to rivaroxaban/warfarin/P2Y12 inhibitors
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Age
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From 18 years old to 80 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be performed via permuted block randomization method. Allocation will be generated via a web based system and consequently concealment will be central using computer software. Unit of randomization will be individual patients and no stratification will be applied.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Blinding will be performed only for the adjudicator level and analyzer level, and patients and physicians won’t be blind in this study
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-08, 1399/03/19
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Ethics committee reference number
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IR.TUMS.THC.REC.1399.004
Health conditions studied
1
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Description of health condition studied
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Pre-acute ST-segment Elevation Myocardial Infarction (STEMI) Left Ventricular (LV) thrombosis
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ICD-10 code
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I23.6
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ICD-10 code description
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Thrombosis of atrium, auricular appendage, and ventricle as current complications following acute myocardial infarction
Primary outcomes
1
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Description
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Resolution of left ventricular thrombus
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Timepoint
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3 months after initiation of antithrombotic therapeutic regimen
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Method of measurement
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Transthoracic echocardiography
Secondary outcomes
1
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Description
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Bleeding after initiation of antithrombotic regimen
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Timepoint
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1 month and 3 months after initiation of antithrombotic regimen
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Method of measurement
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ISTH criteria
Intervention groups
1
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Description
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Intervention group: Rivaroxaban-based antithrombotic therapeutic regimen
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Category
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Treatment - Drugs
2
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Description
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Control group: Warfarin-based antithrombotic therapeutic regimen
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Rajaie cardiovascular medical and research center
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available