NL-OMON55720已完成4 期
Vasospastic angina treatment by Endothelin Receptor Antagonism; a proof of concept study - VERA
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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
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
- •* 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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