EUCTR2018-002623-42-NL进行中（未招募）1 期
Vasospastic angina treatment by Endothelin Receptor Antagonism; a proof of concept study - VERA
Academic Medical Center0 个研究点目标入组 30 人开始时间: 2019年2月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:
- •Male and female patients = 18 and <75 years old;
- •Patients with a high frequency (>3 times per week) and duration of anginal complaints, presumed to be caused by VSA;
- •Absence of significant obstructive coronary artery disease (defined as stenosis > 50% in an epicardial coronary artery) documented by invasive coronary angiography;
- •Supporting evidence of myocardial ischemia or spasm, defined as either:
- •(a) documented dynamic ECG abnormalities during an episode of angina, or
- •(b) documented troponin rise during an episode of angina, or
- •(c) documented coronary spasm during invasive coronary angiography with or without acetylcholine provocation testing;
- •Anginal complaints for at least 3 months despite optimal anti-anginal treatment, which is at the discretion of the treating cardiologist.
- •Signed informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •Patients who are pregnant or nursing and those who plan pregnancy in the period up to 1 months after the study;
- •Women of childbearing potential not using contraception;
- •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.
- •Contraindication for macitentan
- •Patients with active liver disease or severe liver dysfunction with ASAT and/or ALAT >3x upper limit of normal (ULM);
- •Patients with known renal impairment (GFR<60 ml/min);
- •Patients with anemia;
- •Use of potent CYP3A4 inducers (rifampicin, St. John's wort, carbamazepine, phenytoin) due to reduced efficacy of macitentan.
- •Use of potent CYP3A4 inhibitors (itraconazole, ketoconazole, voriconazole, clarithromycin, ritonavir, saquinavir).
研究者
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