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

NCT03786757 | Unknown Phase 3 DMC

• 1 other identifier: Cardiology-LVT Ⅱ
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Conditions

ST Segment Elevation Myocardial Infarction; Left Ventricular Thrombus

Keywords

STEMI; left ventricular thrombus; rivaroxaban

Outcome Measures

Primary Outcomes (2)

• The accumulative percentage of LVT formation at 24 weeks

  The LVT resolve will be determined monthly by follow-up imaging examination (CMR or TTE). The percentage of LVT resolve at 24 weeks will be calculated for each group.

  at 24 weeks

• Bleeding events (ISTH criteria) through the study, an average of 24 weeks

  Bleeding events will be classified by the ISTH criteria. Major bleeding is defined using ISTH criteria as clinically over bleeding that is associated with: 1. A fall in hemoglobin of 2g/dL or more or 2.A transfusion of 2 or more units of packed red blood cells or whole blood, or 3.A critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retropertioneal, or 4. A fatal outcome. All bleeding events will be documented through the study, an average of 24 weeks.

  through the study completion, an average of 24 weeks.

Secondary Outcomes (1)

• Composite major adverse events through the study, an average of 24 weeks

  through the study completion, an average of 24 weeks.

Study Arms (2)

Rivaroxaban

EXPERIMENTAL

rivaroxaban will be added in addition to dual antiplatelet therapy.

Drug: Rivaroxaban

dual antiplatelet therapy (DAPT)

NO INTERVENTION

Conventional dual antiplatelet therapy will be adopted.

Interventions

Rivaroxaban DRUG

Rivaroxaban 2.5mg/BID will be applied for 24 weeks unless severe safety outcome occurs. All patients in both group will take aspirin 100mg/QD, clopidogrel 75mg/QD and proton pump inhibitor during the intervention.

Also known as: Xarelto®

Rivaroxaban

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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);

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (1)

Ren Ji Hospital Affliated to School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, 200127, China

Location

Related Publications (16)

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MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Rivaroxaban

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Jun Pu, Professor

CONTACT

08602168383164; pujun310@hotmail.com

Qin Shao, Professor

CONTACT

08613795376228; shaoqindr@126.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2018
• First Posted: December 26, 2018
• Study Start: April 1, 2019
• Primary Completion: March 30, 2022
• Study Completion: December 30, 2022
• Last Updated: December 26, 2018

Record last verified: 2018-12

Locations

CN (1)