vasospastic angina
Conditions
Interventions
Macitentan
Sponsors
AMC
Eligibility
Inclusion criteria
Inclusion criteria: • Male and female patients = 18 and 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: o documented dynamic ECG abnormalities during an episode of angina, or o (b) documented troponin rise during an episode of angina, or o (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.
Exclusion criteria
Exclusion criteria: • 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The burden of anginal complaints, calculated as: 1. the duration (in minutes) * severity (on a VAS scale 1-10) during the study period up to 2 weeks after discontinuation of the study medication; 2. the frequency of angina attacks * severity (on a VAS scale 1-10) during the study period up to 2 weeks after discontinuation of the study medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy endpoint: • Incidence and severity of angina complaints as obtained by the Seattle Angina Questionnaire during the study period up to 2 weeks after discontinuation of the study medication. Safety endpoints: • Detrimental changes in physical, laboratory or ECG parameters during the study period up to 2 weeks after discontinuation of the study medication. • The occurrence of adverse events (i.e. hospitalization for anginal symptoms and/or myocardial infarction) during the study period up to 2 weeks after discontinuation of the study medication. All possible side effects will be recorded during the study period up to 2 weeks after discontinuation of the study medication. | — |
Contacts
Public ContactRutger Feenstra
Amsterdam UMC-AMC
Outcome results
None listed