The Impact of Vericiguat on Microvascular Function in Patients With Documented Vasospastic Angina Pectoris

Korábbi kezelés

• 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.

Laborértékek

• 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.

Egyéb

• 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

• 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.