Comparison of the safety of rivaroxaban-based versus warfarin-based antithrombotic regimens in patients with acute ST elevation myocardial infarction left ventricular thrombosis
Design
Two parallel groups randomized trial with blinded outcome assessment
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. All patients with the age of 18-80 admitted with acute STEMI event treated with primary percutaneous coronary intervention
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
Intervention groups
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)
Rivaroxaban Versus Warfarin in Patients With Left Ventricular Thrombus After Acute Myocardial Infarction: A Randomized Controlled Pilot Trial
Public title
Rivaroxaban in Left Ventricular Thrombus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with the age of 18-80 admitted with an acute STEMI who have undergone primary percutaneous coronary intervention
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
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding will be performed only for the adjudicator level and analyzer level, and patients and physicians won’t be blind in this study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran Heart Center
Street address
Tehran Heart Center, Jalal-e-Al-e-Ahmad Hwy, Northern Kargar Ave, Tehran province, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1416753955
Approval date
2020-06-08, 1399/03/19
Ethics committee reference number
IR.TUMS.THC.REC.1399.004
Health conditions studied
1
Description of health condition studied
Pre-acute ST-segment Elevation Myocardial Infarction (STEMI) Left Ventricular (LV) thrombosis
ICD-10 code
I23.6
ICD-10 code description
Thrombosis of atrium, auricular appendage, and ventricle as current complications following acute myocardial infarction
Primary outcomes
1
Description
Resolution of left ventricular thrombus
Timepoint
3 months after initiation of antithrombotic therapeutic regimen
Method of measurement
Transthoracic echocardiography
Secondary outcomes
1
Description
Bleeding after initiation of antithrombotic regimen
Timepoint
1 month and 3 months after initiation of antithrombotic regimen