CTIS2022-502998-42-00进行中（未招募）1 期
Vericiguat in Vasospastic Angina (ViVA)
Amsterdam UMC0 个研究点目标入组 55 人开始时间: 2023年3月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 55
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •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.
排除标准
- •Impaired left ventricular function (LVEF<50%), 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, 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, 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
研究者
相似试验
已完成
2 期
The Impact of Vericiguat on Microvascular Function in Patients With Documented Vasospastic Angina PectorisVasospastic AnginaNCT06415227Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)57
尚未招募
不适用
Patients with Angina and MicrOvaScular DysfunctIon treaTed with cardiac non-InVasivE SHOCK wave therapy, a first in man pioneering trial -POSITIVE SHOCKNL-OMON53243cardiologie40
尚未招募
不适用
Spinal Cord Stimulation for Vasospastic Angina Pectoris - a prospective studyAngina Pectoris - Chest Pain10011082NL-OMON53627Amsterdam UMC10
已完成
不适用
A Prospective, Multi-center Clinical Trial for Evaluating the Effectiveness and Safety of Online Coronary Angiography-Derived Index of Microcirculatory Resistance (caIMR)Coronary Microvascular DysfunctionNCT05009667Ge Junbo116
已完成
不适用
The vascular function and coronary artery findings on prognosis of coronary artery diseaseIschemic heart diseaseJPRN-UMIN000036480Jichi Medical University100