Status:
UNKNOWN
Treatment of Post-STEMI Left Ventricular Thrombus With Optimized Anticoagulant
Lead Sponsor:
RenJi Hospital
Collaborating Sponsors:
Shanghai 6th People's Hospital
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Conditions:
ST Segment Elevation Myocardial Infarction
Left Ventricular Thrombus
Eligibility:
All Genders
18-75 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
Despite the fast development and popularization of reperfusion as well as adjunctive medical therapy, complications of STEMI remain critical causes of adverse events. Among them, the formation of the ...
Eligibility Criteria
Inclusion
- Age:18-75 years old.
- 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.
- Left ventricular thrombus (LVT) is detected by either cardiac magnetic resonance (CMR) or TTE in 45 days after symptom onset.
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;
- Severe thrombocytopenia (\<50x109/L), or Anemia (i.e. Hemoglobin \<90g/L) at screening or pre-randomization;
- Liver function Child-Pugh B or C
- Untreated arterial aneurysm, arterial or venous malformation and aorta dissection;
- Body weight \<40kg
- Undergoing anticoagulant therapy before STEMI onset
- Cardiovascular condition
- Cardiac shock
- Uncontrolled blood pressure (SBP\\geq180mmHg);
- Planned CABG within 3months
- Suspicious Pseudo-ventricular aneurysm
- Concomitant diseases
- Severe chronic or acute renal failure (CrCl\<50ml/min at screening or pre-randomization)
- Significantly liver disease
- Current substance abuse (drug or alcohol) problem
- Life expectancy to less than 12 months
- Known allergies, or intolerance to rivaroxaban
- Woman who is currently pregnant, or breastfeeding
- Other hypercoagulable state, such as malignat tumor, SLE
- Other conditions adjudicated by investigators to be unsuitable to anticoagulation
Key Trial Info
Start Date :
February 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
280 Patients enrolled
Trial Details
Trial ID
NCT03764241
Start Date
February 1 2020
End Date
December 30 2023
Last Update
June 1 2023
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