Last updated: May 30, 2023
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting
Phase
3
Condition
Thrombosis
Congestive Heart Failure
Coronary Artery Disease
Treatment
Vitamin K Antagonist
Rivaroxaban
Clinical Study ID
NCT03764241
Cardiology-LVT
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age:18-75 years old.
- Myocardial infarction diagnosed by 1) typical ischemic symptom, 2) elevated ST segmentat 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 leastone value above 99th percentile upper reference limit(UPL); 4) confirmed by coronaryangiography (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
Exclusion Criteria:
- Any contraindication of anticoagulant therapy or unacceptable risk of bleeding
- Active bleeding;
- History of intracranial hemorrhage;
- Clinically significant gastrointestinal bleeding within 12 months beforerandomization;
- Severe thrombocytopenia (<50x109/L), or Anemia (i.e. Hemoglobin <90g/L) atscreening or pre-randomization;
- Liver function Child-Pugh B or C
- Untreated arterial aneurysm, arterial or venous malformation and aortadissection;
- 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 orpre-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
Study Design
Total Participants: 280
Treatment Group(s): 2
Primary Treatment: Vitamin K Antagonist
Phase: 3
Study Start date:
February 01, 2020
Estimated Completion Date:
December 30, 2023
Study Description
Connect with a study center
Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai 200127
ChinaActive - Recruiting
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