Randomized controlled trial of vericiguat in patients with coronary microvascular dysfunction causing stable chest pain (V-COM): study protocol for a randomized control trial
Abstract
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 ischemia 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. Ninety-four patients aged 40-80 years with recurrent stable chest pain, nonobstructive coronary arteries on recent coronary computed tomography (CT) or invasive angiography, and CMD defined by stress CMR (MPR <2.19 or stress MBF <2.19 mL/g/min) will be recruited across six centers in Hong Kong. Participants will be randomized 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 2.5 mg and titrated up to a target dose of 10 mg based on…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
Read the paper
Related studies
- Drug repositioning: a brief overview
- Cyclic nucleotide phosphodiesterases in Drosophila melanogaster
- Time-resolved in silico modeling of fine-tuned cAMP signaling in platelets: feedback loops, titrated phosphorylations and pharmacological modulation
- Current View on Green Tea Catechins Formulations, Their Interactions with Selected Drugs, and Prospective Applications for Various Health Conditions
- In silico Structure-based Identification of Novel Acetylcholinesterase Inhibitors Against Alzheimer’s Disease
- Development and In Vitro Evaluation of Controlled Release Viagra® Containing Poloxamer-188 Using Gastroplus™ PBPK Modeling Software for In Vivo Predictions and Pharmacokinetic Assessments
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.