treatment with vasodilator of chest pain caused by spasm in the vessels of the heart
- Conditions
- Vasospastic angina, i.e. epicardial vasospasm or microvascular coronary dysfunction.MedDRA version: 20.0Level: PTClassification code 10002383Term: Angina pectorisSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2018-002623-42-NL
- Lead Sponsor
- Academic Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 30
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method