Vasospastic AnginaPhase 2ViVANCT06415227
The Impact of Vericiguat on Microvascular Function in Patients With Documented Vasospastic Angina Pectoris
A Phase 2 study testing Vericiguat in people with Vasospastic Angina, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vasospastic Angina
- What is being tested?
- Vericiguat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 57 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2025to 13 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Impaired left ventricular function (LVEF<50%)
- Significant valvular pathology
- 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.
- Known hypersensitivity to the active substance or to any of the excipients (Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate).
- Concomitant use of other soluble guanylate cyclase (sGC) stimulators, such as riociguat.
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- Concomitant use PDE5 inhibitors, such as sildenafil.
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vericiguat in Vasospastic Angina
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.
- Conditions
- Vasospastic Angina
- Being tested
- Vericiguat
- Medical subject headings
- Angina Pectoris, Variant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VericiguatDrug
Also called Verquvo
The target dose of vericiguat is 10 milligrams once daily, which will be started at 2.5mg once daily and uptitrated every two weeks to reach the target dose. Dose modification will depend on mean sitting systolic blood pressure and the absence of symptoms indicative of hypotension. The intention of the protocol is to reach and maintain the target study drug dose after completion of uptitration. If the dose is temporarily interrupted, then resumption of study drug treatment and continued uptitration will be considered at any subsequent visit when the investigator feels it is medically appropriate. Vericiguat will be taken orally once daily at about the same time.
| Study group | Role | What they receive |
|---|---|---|
| Vericiguat (2.5 mg, 5 mg and 10 mg) first; placebo second | Experimental | Treatment with Vericiguat will be uptitrated every two weeks to the highest tolerated dose, with a target maintenance dose of maximum 10 mg once daily. After a washout period of 2 weeks, matching placebo will be started and is uptitrated every two weeks to maintain double blinding. Receives: Drug: Vericiguat |
| Placebo first; Vericiguat (2.5 mg, 5 mg and 10 mg) second | Placebo comparator | Matching placebo is uptitrated every two weeks to maintain double blinding. After a washout period of 2 weeks, treatment with Vericiguat will be started and is uptitrated every two weeks to the highest tolerated dose, with a target maintenance dose of maximum 10 mg once daily. Receives: Drug: Vericiguat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular function assessed with LASCA : Area under the curve for cutaneous microvascular conductance during acetylcholine iontophoresis
Difference in area under the curve for cutaneous microvascular conductance in APU/s during acetylcholine iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods
Measured: 10-week and 22-week follow-up
Secondary outcomes (29)
Microvascular function assessed with LASCA : Peak cutaneous microvascular conductance during acetylcholine iontophoresis
Difference in peak cutaneous microvascular conductance in APU/mmHg during acetylcholine iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA : Absolute and relative change in cutaneous microvascular conductance (peak-baseline) during acetylcholine iontophoresis.
Difference in the absolute and relative change in cutaneous microvascular conductance from baseline conditions to peak conductance during acetylcholine iontophoresis in APU/mmHg after 10-week placebo- versus 10-week vericiguat treatment.
Measured: 10-week and 22-week follow-up
Vasodilator function assessed with EndoPAT.
Difference in vasodilator function assessed with EndoPAT after 10-week placebo versus 10-week vericiguat treatment expressed by the Reactive hyperemia index (RHI), calculated as the index of signal amplitude pre-to-post occlusion in the occluded arm, divided by the same ratio in the control arm.
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA on placebo versus vericiguat treatment using SNP and insulin.
Difference in cutaneous microvascular conductance in APU/mmHg during SNP or insulin iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA on placebo versus vericiguat treatment using SNP and insulin.
Difference in the area under the curve for cutaneous microvascular conductance in APU/s during SNP or insulin iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment
Difference in peak cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg).
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment
Difference in area under the curve for cutaneous microvascular conductance in APU/s after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg).
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment
Difference in absolute and relative changes in cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg).
Measured: 10-week and 22-week follow-up
Vasodilator function assessed with EndoPAT stratified by the vericiguat dose reached during the treatment
Difference in reactive hyperemia index (RHI) after 10-week placebo versus 10-week vericiguat treatment stratified by the vericiguat dose reached during the treatment phase (5 or 10mg). RHI is calculated as the index of signal amplitude pre-to-post occlusion in the occluded arm, divided by the same ratio in the control arm.
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype.
Difference in peak cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype.
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype.
Difference in area under the curve for cutaneous microvascular conductance in APU/s after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype.
Measured: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype.
Difference in absolute and relative changes in cutaneous microvascular conductance in APU/mmHg after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype.
Measured: 10-week and 22-week follow-up
Vasodilator function assessed with EndoPAT stratified by epicardial or microvascular vasospasm endotype.
Difference in reactive hyperemia index (RHI) after 10-week placebo versus 10-week vericiguat treatment stratified by epicardial or microvascular vasospasm endotype. RHI is calculated as the index of signal amplitude pre-to-post occlusion in the occluded arm, divided by the same ratio in the control arm.
Measured: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by the ORBITA-2 application after 10-week placebo versus 10-week vericiguat treatment periods.
Measured: 10-week snd 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by the Seattle Angina Questionnaire (SAQ) Summary Score after 10-week placebo versus 10-week vericiguat treatment periods. The SAQ summary score ranges from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life.
Measured: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by the Rose Dyspnea Score after 10-week placebo versus 10-week vericiguat treatment periods. The Rose Dyspnea Scale is a four-item questionnaire that assesses a patients' dyspnea level with common activities. One point is assigned to each activity associated with dyspnea. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea.
Measured: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by EQ-5D-5L (EuroQol - 5 dimensions - 5 levels. A self-assessed, health-related, quality of life questionnaire) scores after 10-week placebo versus 10-week vericiguat treatment periods. The five severity levels in the EQ-5D-5L are 'no problems', 'slight problems', 'moderate problems', 'severe problems' and 'unable to/extreme problems'.
Measured: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by the EQ visual analogue scale (EQ-VAS) scores after 10-week placebo versus 10-week vericiguat treatment periods. The EQ VAS component contains a scaled vertical line ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine') where respondents rate their overall health status.
Measured: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by iPCQ (iMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire) index score after 10-week placebo versus 10-week vericiguat treatment periods. The scoring of the iPCQ questionnaire involves three modules assessing productivity losses due to absenteeism (1), presenteeism (2), and productivity losses associated with unpaid work (3). Scores are calculated in costs with a higher score indicating higher productivity loss.
Measured: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Difference in quality of life measured by iMCQ (iMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire) index score after 10-week placebo versus 10-week vericiguat treatment periods. The scoring of the iMCQ questionnaire involves calculating medical consumption by assessing respondents' answers to relevant questions, which inquire about various forms of care and the frequency of their utilization. A higher score indicates higher health care consumption.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change in quality of life measured by the ORBITA-2 application from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change in quality of life measured by the Seattle Angina Questionnaire (SAQ) Summary Score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The SAQ summary score ranges from 0 to 100 with higher scores indicating less angina, fewer functional limitations, and better quality of life.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change of quality of life measured by the Rose Dyspnea Score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The Rose Dyspnea Scale is a four-item questionnaire that assesses a patients' dyspnea level with common activities. One point is assigned to each activity associated with dyspnea. Scores range from 0 to 4, where 0 indicates no dyspnea with activity and 4 indicates significant limitations due to dyspnea.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change of quality of life measured by the EQ-5D-5L (EuroQol - 5 dimensions - 5 levels. A self-assessed, health-related, quality of life questionnaire) scores from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods.The five severity levels in the EQ-5D-5L are 'no problems', 'slight problems', 'moderate problems', 'severe problems' and 'unable to/extreme problems'.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change of quality of life measured by the EQ visual analogue scale (EQ-VAS) scores from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods.The EQ VAS component contains a scaled vertical line ranging from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine') where respondents rate their overall health status.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change of quality of life measured by the iPCQ (iMTA (Institute for Medical Technology Assessment) Productivity Cost Questionnaire) index score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The scoring of the iPCQ questionnaire involves three modules assessing productivity losses due to absenteeism (1), presenteeism (2), and productivity losses associated with unpaid work (3). Scores are calculated in costs with a higher score indicating higher productivity loss.
Measured: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Difference in the change of quality of life measured by the iMCQ (iMTA (Institute for Medical Technology Assessment) Medical Consumption Questionnaire) index score from baseline (prior to randomization) to 10-week placebo and 10-week vericiguat treatment periods. The scoring of the iMCQ questionnaire involves calculating medical consumption by assessing respondents' answers to relevant questions, which inquire about various forms of care and the frequency of their utilization. A higher score indicates higher health care consumption.
Measured: 10-week and 22-week follow-up
Angina burden
Angina burden calculated by the frequency of angina attacks for placebo versus vericiguat treatment periods
Measured: 10-week and 22-week follow-up
The occurrence of major adverse cardiac events
The occurrence of major adverse cardiac events (hospitalization for angina, spontaneous myocardial infarction, unplanned revascularization, death) during the study period.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start10 Feb 2025
- Primary completion13 Jul 2026
- Study completion13 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vasospastic AnginaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Principal investigator, Jan J. Piek, MD, PhD, Amsterdam University Medical Center (UMC), Location Academic Medical Center (AMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06415227
- Sponsor's protocol ID
- EU CT 2022-502998-42-00
- Acronym
- ViVA
- Status last verified
- Jul 2026
- First submitted
- 25 Apr 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Namba HF, de Jong EAM, Dimitriu-Leen AC, Meuwissen M, Heestermans TACM, den Haan MC, Beijk MAM, Vos NS, Boerhout CKM, Mechroubi A, Nijkamp T, Mohsin M, Escaned J, den Ruijter HM, Appelman Y, Vink AS, Eringa EC, Delewi R, Piek JJ, Damman P, van de Hoef TP. Vericiguat for the Treatment of Coronary Vasospasm (ViVA): A Double-Blind Placebo-Controlled Randomized Crossover Trial. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07591-1. doi: 10.1016/j.jacc.2026.08.037. Online ahead of print.
PubMed 42670734Namba HF, de Jong EAM, Boerhout CKM, Mechroubi A, Nijkamp T, Damman P, Dimitriu-Leen AC, Meuwissen M, Heestermans TACM, den Haan MC, Beijk MAM, Vos NS, Escaned J, den Ruijter HM, Appelman Y, Eringa EC, Delewi R, Piek JJ, van de Hoef TP. Rationale and design of the vericiguat in vasospastic angina (ViVA) trial: A double-blind placebo-controlled randomized cross-over study. Am Heart J. 2026 Sep;299:107451. doi: 10.1016/j.ahj.2026.107451. Epub 2026 Apr 23.
PubMed 42034271
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vericiguat in Vasospastic Angina
- ClinicalTrials.gov ID
- NCT06415227
- Acronym / sponsor ID
- ViVA / EU CT 2022-502998-42-00
- Conditions
- Vasospastic Angina
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Bayer
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 13 Jul 2026 (actual)
- Study completion
- 13 Jul 2026 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vericiguat (2.5 mg, 5 mg and 10 mg) first; placebo second | Experimental | Drug: VericiguatTreatment with Vericiguat will be uptitrated every two weeks to the highest tolerated dose, with a target maintenance dose of maximum 10 mg once daily. After a washout period of 2 weeks, matching placebo will be started and is uptitrated every two weeks to maintain double blinding. |
| Placebo first; Vericiguat (2.5 mg, 5 mg and 10 mg) second | Placebo comparator | Drug: VericiguatMatching placebo is uptitrated every two weeks to maintain double blinding. After a washout period of 2 weeks, treatment with Vericiguat will be started and is uptitrated every two weeks to the highest tolerated dose, with a target maintenance dose of maximum 10 mg once daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- Impaired left ventricular function (LVEF<50%)
- Significant valvular pathology
- 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.
- Known hypersensitivity to the active substance or to any of the excipients (Microcrystalline cellulose, croscarmellose sodium, hypromellose 2910, lactose monohydrate, magnesium stearate, sodium laurilsulfate).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VericiguatAlso: VerquvoThe target dose of vericiguat is 10 milligrams once daily, which will be started at 2.5mg once daily and uptitrated every two weeks to reach the target dose. Dose modification will depend on mean sitting systolic blood pressure and the absence of symptoms indicative of hypotension. The intention of the protocol is to reach and maintain the target study drug dose after completion of uptitration. If the dose is temporarily interrupted, then resumption of study drug treatment and continued uptitration will be considered at any subsequent visit when the investigator feels it is medically appropriate. Vericiguat will be taken orally once daily at about the same time. | Drug | Placebo first; Vericiguat (2.5 mg, 5 mg and 10 mg) second, Vericiguat (2.5 mg, 5 mg and 10 mg) first; placebo second |
Primary outcome
Microvascular function assessed with LASCA : Area under the curve for cutaneous microvascular conductance during acetylcholine iontophoresis
Time frame: 10-week and 22-week follow-up
Difference in area under the curve for cutaneous microvascular conductance in APU/s during acetylcholine iontophoresis after 10-week placebo- versus 10-week vericiguat treatment periods
29 secondary outcomes
Microvascular function assessed with LASCA : Peak cutaneous microvascular conductance during acetylcholine iontophoresis
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA : Absolute and relative change in cutaneous microvascular conductance (peak-baseline) during acetylcholine iontophoresis.
Time frame: 10-week and 22-week follow-up
Vasodilator function assessed with EndoPAT.
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA on placebo versus vericiguat treatment using SNP and insulin.
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA on placebo versus vericiguat treatment using SNP and insulin.
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by the vericiguat dose reached during the treatment
Time frame: 10-week and 22-week follow-up
Vasodilator function assessed with EndoPAT stratified by the vericiguat dose reached during the treatment
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype.
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype.
Time frame: 10-week and 22-week follow-up
Microvascular function assessed with LASCA stratified by epicardial or microvascular vasospasm endotype.
Time frame: 10-week and 22-week follow-up
Vasodilator function assessed with EndoPAT stratified by epicardial or microvascular vasospasm endotype.
Time frame: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week snd 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week and 22-week follow-up
Quality of life between vericiguat treatment and placebo
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Quality of life between baseline and end of treatment
Time frame: 10-week and 22-week follow-up
Angina burden
Time frame: 10-week and 22-week follow-up
The occurrence of major adverse cardiac events
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Derived from this study: PubMed 42670734Namba HF, de Jong EAM, Dimitriu-Leen AC, Meuwissen M, Heestermans TACM, den Haan MC, Beijk MAM, Vos NS, Boerhout CKM, Mechroubi A, Nijkamp T, Mohsin M, Escaned J, den Ruijter HM, Appelman Y, Vink AS, Eringa EC, Delewi R, Piek JJ, Damman P, van de Hoef TP. Vericiguat for the Treatment of Coronary Vasospasm (ViVA): A Double-Blind Placebo-Controlled Randomized Crossover Trial. J Am Coll Cardiol. 2026 Aug 28:S0735-1097(26)07591-1. doi: 10.1016/j.jacc.2026.08.037. Online ahead of print.
- Derived from this study: PubMed 42034271Namba HF, de Jong EAM, Boerhout CKM, Mechroubi A, Nijkamp T, Damman P, Dimitriu-Leen AC, Meuwissen M, Heestermans TACM, den Haan MC, Beijk MAM, Vos NS, Escaned J, den Ruijter HM, Appelman Y, Eringa EC, Delewi R, Piek JJ, van de Hoef TP. Rationale and design of the vericiguat in vasospastic angina (ViVA) trial: A double-blind placebo-controlled randomized cross-over study. Am Heart J. 2026 Sep;299:107451. doi: 10.1016/j.ahj.2026.107451. Epub 2026 Apr 23.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vericiguat in people with Vasospastic Angina, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular function assessed with LASCA : Area under the curve for cutaneous microvascular conductance during acetylcholine iontophoresis (time frame: 10-week and 22-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06415227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.