Efficacy of endothelin receptor antagonism in treatment of coronary artery spasm: a randomized controlled clinical trial.

Conditions

Coronary vasomotor dysfunction (spasm), Coronary vasospasm

Brief summary

Successful treatment is defined as absence of epicardial vasospasm according to COVADIS criteria (see Table 1 explanatory text in protocol) during repeat spasm provocation test at 10 weeks.

Detailed description

Angina relief. The mean within subject change in SAQSS from baseline to 10 weeks is assessed and compared between bosentan and placebo group., Explorative: Anginal complaints and quality of life, Explorative: Microvascular spasm, Explorative: Endothelin levels, Explorative: Improvement, deterioration or no effect on spasm, Explorative safety endpoint: by means of repeat laboratory analysis, blood pressure measurements and the occurrence of major adverse cardiovascular events (MACE), other adverse events (hospitalization for hypotension, angina or myocardial infarction) and rate and reason of study drug discontinuation / study withdrawal

Crooijmans C, Jansen T, van de Hoef T, Paradies V, de Vos A, Yosofi B, Cetinyurek-Yavuz A, den Ruijter H, Beijk M, Meuwissen M, van Royen N, Elias-Smale S, Dimitriu-Leen A, Damman P, for NL-CFT.

2025-04-22

10.1016/j.ahj.2025.04.022

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGMICROCRYSTALLINE CELLULOSE

DRUGBosentan Abdi 62

DRUG5 mg filmomhulde tabletten

DRUGBosentan Accord 125 mg filmomhulde tabletten

DRUGBosentan Accord 62

DRUGBosentan Abdi 125 mg filmomhulde tabletten

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Successful treatment is defined as absence of epicardial vasospasm according to COVADIS criteria (see Table 1 explanatory text in protocol) during repeat spasm provocation test at 10 weeks.	—

Secondary

Measure	Time frame
Angina relief. The mean within subject change in SAQSS from baseline to 10 weeks is assessed and compared between bosentan and placebo group., Explorative: Anginal complaints and quality of life, Explorative: Microvascular spasm, Explorative: Endothelin levels, Explorative: Improvement, deterioration or no effect on spasm, Explorative safety endpoint: by means of repeat laboratory analysis, blood pressure measurements and the occurrence of major adverse cardiovascular events (MACE), other adverse events (hospitalization for hypotension, angina or myocardial infarction) and rate and reason of study drug discontinuation / study withdrawal	—

Measure

Time frame

Angina relief. The mean within subject change in SAQSS from baseline to 10 weeks is assessed and compared between bosentan and placebo group., Explorative: Anginal complaints and quality of life, Explorative: Microvascular spasm, Explorative: Endothelin levels, Explorative: Improvement, deterioration or no effect on spasm, Explorative safety endpoint: by means of repeat laboratory analysis, blood pressure measurements and the occurrence of major adverse cardiovascular events (MACE), other adverse events (hospitalization for hypotension, angina or myocardial infarction) and rate and reason of study drug discontinuation / study withdrawal

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Countries

Netherlands

Outcome results

None listed