Prevention of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant (EARLYmyo-LVT Ⅱ)

• Status: Not yet recruiting
• Trial end date: 2022-12-30
• Target enrollment: 0
• Participant gender: All

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 safety outcomes of Rivaroxaban on the prevention of post-STEMI left ventricular thrombus.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: RenJi Hospital
• Treatments: Anticoagulants; Rivaroxaban

Criteria

Inclusion Criteria:

• 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 Criteria:

• Any contraindication of anticoagulant therapy or unacceptable risk of bleeding

1. Active bleeding;

2. History of intracranial hemorrhage;

3. Clinically significant gastrointestinal bleeding within 12 months before randomization;

4. Thrombocytopenia, unknown severe anemia at screening or pre-randomization;

5. 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

1. After heart valvular replacement;

2. History of PCI or CABG;

3. Subacute bacterial endocarditis;

4. Venous thrombus, pulmonary thrombi embolism and other thrombophilia under anti-thrombotic therapy.

• Complex heart condition

1. Cardiac shock (persistent SBP<90 mmHg accompanies with deficient organ perfusion after fluid infusion);

2. Has ventricular arrhythmias refractory to treatment at the time of randomization

3. Uncontrolled blood pressure (SBP≥160mmHg);

4. Undergone or has a CABG planned.

• Severe complication

1. Body weigh <40kg or >125kg;

2. Severe chronic or acute renal failure (CrCl <30 mL/min at screening or pre-randomization);

3. 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;

4. Severe anemia (i.e. Hemoglobin<9g/dL) at screening or pre-randomization;

5. Has a current substance abuse (drug or alcohol) problem or a history within the previous 6 months;

6. Has any severe condition that would limit life expectancy to less than 12 months;

7. Known allergies, hypersensitivity, or intolerance to rivaroxaban;

8. Woman who is pregnant, breastfeeding or planning to become pregnant while enrolled in this study;

9. 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.