Prophylactic Rivaroxaban Therapy for Left Ventricular Thrombus After Anterior ST-Segment Elevation Myocardial Infarction.
Zhongfan Zhang, Daoyuan Si, Qian Zhang...
https://pubmed.ncbi.nlm.nih.gov/35367170/Actively Recruiting
Led by National Institute of Cardiovascular Diseases, Pakistan · Updated on 2024-12-19
472
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the safety and effectiveness of low-dose Apixaban combined with standard medical therapy compared to standard therapy alone to prevent left ventricular LV thrombus formation after primary PCI in patients with acute anterior myocardial infarction and severe LV dysfunction. This open-label, randomized controlled trial focuses on patients aged 18 to 65 years with an ejection fraction below 35% and specific heart motion abnormalities. Participants will be randomly assigned to receive either Apixaban 2.5 mg twice daily plus dual antiplatelet therapy aspirin and clopidogrel for four weeks along with guideline-directed medical therapy, or guideline-directed medical therapy alone including dual antiplatelet therapy. After four weeks, those in the Apixaban group will continue with dual antiplatelet therapy. In case of stent thrombosis, some medication adjustments may be made. Follow-up includes phone assessments at two weeks and an in-person visit with echocardiography at four weeks. During the study, participants will be monitored for LV thrombus formation using echocardiography at four weeks, and clinical status, medication side effects, and adherence will be assessed. The primary outcome is the incidence of LV thrombus formation at one month. Secondary measures include rates of death, recurrent heart attacks, stent thrombosis, heart failure hospitalizations, bleeding events, and drug discontinuation due to side effects. Safety and outcomes will be independently reviewed by a clinical events committee.
CONDITIONS
Apixaban Prophylaxis for Prevention of Left Ventricular Thrombus Following Anterior Myocardial Infarction
A
Abdul Hakeem, MD FACC FSCAI FASE
S
Sabha Bhatti, MD FASE FASNC FACC
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National Institute of Cardiovascular Diseases, Pakistan
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants receive either Apixaban 2.5 mg twice daily plus dual antiplatelet therapy (DAPT) for four weeks or standard care with DAPT and guideline directed medical therapy. After four weeks, the treatment group switches to DAPT alone.
1 baseline visit and 1 follow-up visit
Duration - Up to 4 weeks
Participants are monitored for clinical status, side effects, medication compliance, and incidence of left ventricular thrombus formation with echocardiography at 4 weeks.
1 phone call at 2 weeks and 1 in-person visit at 4 weeks
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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Lead Sponsor