The goal of this clinical trial is to to evaluate the effect of oral isosorbide mononitrate plus amlodipine antispasm therapy on outcomes of radial artery grafts in patients underwent primary isolated CABG. The main question it aims to answer is: Whether the oral isosorbide mononitrate plus amlodipine antispasm therapy could reduce the failure outcome of radial artery grafts after CABG . Researchers will compare isosorbide mononitrate plus amlodipine to none to see if isosorbide mononitrate plus amlodipine works. Participants will 1. Take oral isosorbide mononitrate (20-40mg daily) plus amlodipine (2.5-5mg daily) therapy for 24 weeks after CABG. 2. Clinical follow-up at Week 1, 4, 12, and 24 after CABG. 3. Protocol-driven CCTA at Week 24 after CABG.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Oral isosorbide mononitrate 40mg (if unable to tolerate, 20mg) once daily + amlodipine 5mg (if unable to tolerate, 2.5mg) once daily for 24 weeks after CABG
Ruijin Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
The rate of RA graft failure at Week 24
A protocol-driven CCTA will be used to evaluate the RA graft outcome at Week 24 after CABG. Fitzgibbon Grade B/S/O is definned as Graft Failure.
Time frame: at Week 24
The time to first Major Adverse Cardiovascular Event (MACE)
MACE is a composite of all-cause death, myocardial infarction（including peri-operative MI and silent MI), stroke and unplanned revascularization.
Time frame: within 24 weeks
The proportion of participants with at least once symptomatic hypotension
Time frame: within 24 weeks
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