The V-COM trial will randomize 94 patients to evaluate whether 6 months of vericiguat improves stress myocardial blood flow and myocardial perfusion reserve in coronary microvascular dysfunction.
RCT (n=94)
Single-blind
1:1
Yes
Does vericiguat improve stress myocardial blood flow and myocardial perfusion reserve in patients with stable chest pain and INOCA caused by CMD?
This study protocol outlines a randomized controlled trial to evaluate whether vericiguat improves myocardial perfusion in patients with coronary microvascular dysfunction and stable chest pain.
BACKGROUND: Previous studies have shown that ~50% of patients with stable chest pain have no obstructive coronary artery disease (CAD), yet remain at higher risk of major adverse cardiovascular events (MACE) compared to patients without chest pain. Coronary microvascular dysfunction (CMD) is a major cause of ischaemia with no obstructive coronary arteries (INOCA). While therapies for CMD are lacking, Vericiguat, a soluble guanylate cyclase stimulator, has shown improvement in coronary microvascular circulation in animal studies. Quantitative stress cardiovascular magnetic resonance (CMR) allows the quantification of stress myocardial blood flow (MBF) and myocardial perfusion reserve (MPR). This study aims to conduct a randomized controlled trial to determine if Vericiguat improves MBF and MPR in patients with stable chest pain and INOCA caused by CMD. METHODS/DESIGN: V-COM is a single-blind, randomized controlled trial. 94 patients aged 40-80 years with recurrent stable chest pain, non-obstructive coronary arteries on recent coronary computed tomography (CT) or invasive angiography, and CMD defined by stress CMR (MPR <2.19 or stress MBF <2.19ml/g/min) will be recruited across six centres in Hong Kong. Participants will be randomised 1:1 to vericiguat plus optimal medical therapy (intervention) or optimal medical therapy alone (control). Vericiguat will be prescribed once daily for 6 months, starting at 2.5mg and titrated up to a target dose of 10mg based on systolic blood pressure and tolerability. CMR (including quantitative stress perfusion) will be performed at baseline and 6 months. The primary outcome is the between-group difference in change in stress MBF and MPR from baseline to 6 months. Secondary outcomes include change in six-minute walk distance and Seattle Angina Questionnaire-7 (SAQ-7) scores. DISCUSSION: This study will provide evidence on whether Vericiguat can improve myocardial perfusion in patients with CMD and offer insights into its potential as a novel therapy for CMD.
Lo et al. (Fri,) conducted a rct in Coronary Microvascular Dysfunction causing Stable Chest Pain (n=94). Vericiguat vs. Optimal medical therapy alone was evaluated on Between-group difference in change in stress MBF and MPR from baseline to 6 months. The V-COM trial will randomize 94 patients to evaluate whether 6 months of vericiguat improves stress myocardial blood flow and myocardial perfusion reserve in coronary microvascular dysfunction.