NCT06415227CompletedPhase 2
The Impact of Vericiguat on Microvascular Function in Patients With Documented Vasospastic Angina Pectoris
Vericiguat in Vasospastic Angina
Source: ClinicalTrials.gov · Last updated 29 Jul 2026
Brief summary (registry, in English)
Vasospastic angina is increasingly recognized as an important contributor to anginal symptoms in patients with non-obstructive coronary artery disease (ANOCA). Endothelial dysfunction and smooth muscle cell dysfunction are considered elementary in the development of vasospastic angina. As one of many functions, the vascular endothelium regulates local vascular tone, mainly through the vasodilatory effect of endothelium-derived nitric oxide (NO). Vericiguat is a soluble guanylate cyclase (sGC) stimulator and thereby acts directly on the NO signalling pathway from the endothelium towards the vascular smooth muscle cells. As such, Vericiguat potentially has an beneficial therapeutic effect in patients with vasospastic angina.The VIVA study aims to demonstrate the effect of Vericiguat on endothelial function and microvascular vasodilator responses, as well as its tolerability and safety in patients with vasospastic angina as the pathophysiological substrate of ANOCA.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 25 Apr 2024
- Start date
- 10 Feb 2025
- Primary completion date
- 13 Jul 2026
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diseases
- Coronary artery disease
- NCT number
- NCT06415227
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 57
- From 10 Feb 2025 to the primary completion date, 13 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication for treatment with sublingual nitrates as background medication only, at the discretion of the treating cardiologist.
- Contraindications for treatment with vericiguat: resting systolic blood pressure\<100mmHg, severe renal impairment (estimated glomerular filtration rate \<15ml/min), severe hepatic impairment.
- Concomitant use of other soluble guanylate cyclase (sGC) stimulators, such as riociguat.
- Concomitant use PDE5 inhibitors, such as sildenafil.
Lab values
- Impaired left ventricular function (LVEF\<50%)
- Known hypersensitivity to the active substance or to any of the excipients (Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate).
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
Other
- Significant valvular pathology
- Patients who are pregnant or nursing and those who plan pregnancy in the period up to 1 month after the study;
- Patients with a limited life expectancy less than one year;
- Patients unable to provide written informed consent, or are otherwise not suitable for inclusion according to the investigator
Who the study is looking for
- Age \>18 years
- Recurrent angina symptoms provoked by exercise and/or repeated attacks of angina at rest at least once weekly despite current medical treatment.
- Absence of (co-existing) flow-limiting coronary artery stenosis (as defined by any coronary artery diameter reduction \>50%, or fractional flow reserve≤0.80, or instantaneous wave-free ratio/resting full cycle ratio ≤0.89).
- Unambiguous epicardial and/or microvascular coronary vasospasm according to the COVADIS criteria, documented by invasive acetylcholine provocation testing.
- A female participant is eligible to participate if at least one of the following conditions applies: Women with a confirmed post-menopausal state (defined as amenorrhea for at least 12 months without an alternative medical cause); or premenopausal women with documented hysterectomy, documented bilateral salpingectomy or documented bilateral oophorectomy; or for women of childbearing potential: Negative highly sensitive urine or serum pregnancy test within 24 hours the first dose of study intervention and practicing a highly effective birth control method (failure rate of less than 1%) during the study intervention period / and for at least one month after the last dose of study intervention: progestogen-only subdermal contraceptive implant, intrauterine system (progestin releasing intrauterine device), non-hormonal intrauterine device, bilateral tubal occlusion, azoospermic partner (vasectomized or secondary to medical cause) or heterosexual abstinence.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Amsterdam UMC Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.