Status:
UNKNOWN
Prevention of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant (EARLYmyo-LVT Ⅱ)
Lead Sponsor:
RenJi Hospital
Conditions:
ST Segment Elevation Myocardial Infarction
Left Ventricular Thrombus
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Left ventricular thrombus is a common complication subsequent to ST-segment elevation myocardial infarction (STEMI) that related to increased embolic events. This study aims to assess the efficacy and...
Detailed Description
According to the newest JAMA review, the incidence of left ventricular thrombus (LVT) in the ST-segment elevation myocardial infarction (STEMI) infarction patients is 15%, with particularly 25% in the...
Eligibility Criteria
Inclusion
- Age:18-80 years old.
- Anterior myocardial infarction diagnosed by 1) typical ischemic symptom, 2) elevated ST segment at the J-point in two contiguous leads (ST elevation should be ≥2mm in men ≥40years; ≥2.5mm in men \<40years, or ≥1.5mm in women regardless of age in leads V2 and V3; and ≥1mm in leads other than V2 and V3 ); 3) elevated cardiac troponin value with at least one value above 99th percentile upper reference limit（UPL); 4) confirmed by coronary angiography (CAG) or imaging evidence of new loss of anterior myocardium.
- LVEF \< 40% or left ventricular aneurysm detected by either cardiac magnetic resonance (CMR) or TTE during hospitalization.
Exclusion
- Any contraindication of anticoagulant therapy or unacceptable risk of bleeding
- Active bleeding;
- History of intracranial hemorrhage;
- Clinically significant gastrointestinal bleeding within 12 months before randomization;
- Thrombocytopenia, unknown severe anemia at screening or pre-randomization;
- Arterial aneurysm, arterial or venous malformation and aorta dissection.
- Except for subjects who are taking anti-thrombotic therapy (anticoagulation or anti-platelet) at the time of screening
- After heart valvular replacement;
- History of PCI or CABG;
- Subacute bacterial endocarditis;
- Venous thrombus, pulmonary thrombi embolism and other thrombophilia under anti-thrombotic therapy.
- Complex heart condition
- Cardiac shock (persistent SBP\<90 mmHg accompanies with deficient organ perfusion after fluid infusion);
- Has ventricular arrhythmias refractory to treatment at the time of randomization
- Uncontrolled blood pressure (SBP≥160mmHg);
- Undergone or has a CABG planned.
- Severe complication
- Body weigh \<40kg or \>125kg;
- Severe chronic or acute renal failure (CrCl \<30 mL/min at screening or pre-randomization);
- Significantly liver disease，or liver function test abnormal at screening (confirmed with repeat test): ALT \>5 times the upper limit of normal or 3 times the upper limits of normal plus total bilirubin \>2 times the upper limits of normal;
- Severe anemia (i.e. Hemoglobin\<9g/dL) at screening or pre-randomization;
- Has a current substance abuse (drug or alcohol) problem or a history within the previous 6 months;
- Has any severe condition that would limit life expectancy to less than 12 months;
- Known allergies, hypersensitivity, or intolerance to rivaroxaban;
- Woman who is pregnant, breastfeeding or planning to become pregnant while enrolled in this study;
- Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (egg, compromise the well-being) of the subject or that could prevent, limit or confound the protocol-specified assessments.
- Left ventricular thrombus (LVT) detected by either cardiac magnetic resonance (CMR) or TTE during hospitalization.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03786757
Start Date
April 1 2019
End Date
December 30 2022
Last Update
December 26 2018
Active Locations (1)
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1
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China, 200127