Clinical Trials Directory

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RecruitingNCT06239974

Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)

Randomised Controlled Trial of Vericiguat in Patients With Coronary Microvascular Dysfunction Causing Stable Chest Pain (V-COM)

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
94 (estimated)
Sponsor
The University of Hong Kong · Academic / Other
Sex
All
Age
40 Years – 75 Years
Healthy volunteers
Not accepted

Summary

This is a randomised controlled trial to determine the effectiveness of Vericiguat to improve stress myocardial blood flow (MBF) and myocardial perfusion reserve as measured by cardiac magnetic resonance (CMR) imaging.

Detailed description

Stable chest pain is one of the most common complaints by patients. However, about 50% of patients referred for catheter coronary angiograms do not have obstructive coronary artery disease (CAD). In the United Kingdom (UK), one very large population study showed that \~70% of patients did not have a cause for the chest pain diagnosed within 6 months of presentation. Furthermore, the study further showed that this group of patients had a significantly higher risk of major adverse cardiovascular events (MACE) compared to patients without chest pain. It is now understood that the two major causes of cardiac chest pain with non obstructive CAD (also known as Ischaemia with Non Obstructive Coronary Arteries (INOCA)) are coronary microvascular dysfunction (CMD) and the other is coronary vasospasm. CMD and coronary vasospasm have been shown in one randomised controlled study to comprise 52% and 17% of all patients with INOCA. However, therapies for CMD are lacking and has been highlighted as a major area of need.

Conditions

Interventions

TypeNameDescription
DRUGVericiguatPatients will be prescribed vericiguat once a day for 6 months, starting at 2.5mg and titrated up to the full dose of 10mg per day (doubling of dose every 2 weeks) in addition to optimised medical therapy and standard follow-up like the control group
DIAGNOSTIC_TESTStress Cardiac Magnetic ResonanceAll patients will have stress CMR examinations at recruitment and at the end of trial.

Timeline

Start date
2024-09-01
Primary completion
2027-08-31
Completion
2027-08-31
First posted
2024-02-02
Last updated
2025-10-07

Locations

1 site across 1 country: Hong Kong

Source: ClinicalTrials.gov record NCT06239974. Inclusion in this directory is not an endorsement.