Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm (NCT06432452) | Clinical Trial Compass
By InvitationPhase 2/3
Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm
Netherlands100 participantsStarted 2024-11-11
Plain-language summary
The goal of this randomized clinical trial is to assess if adjunctive bosentan therapy, in comparison to placebo, can reduce the rate of epicardial vasospasm at follow-up spasm provocation CFT (fuCFT) in patients with previously proven epicardial vasospasm on acetylcholine reactivity testing (at index CFT) and ongoing angina(-like) complaints.
Participants will
* Use either endothelin receptor antagonist or placebo for 10 weeks
* Undergo follow-up acetylcholine spasm provocation test after 10 weeks
* Answer online questionnaires on angina and quality of life
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Definitive diagnosis of epicardial vasospasm on maximal acetylcholine dose of 100µg (at iCFT)
✓. At least 18 years of age
✓. On optimal regular care ( current or previous treatment with at least 2 daily anti-anginal medicines i.e. nitrate and calcium channel blocker
✓. Continuing episodes of angina(-like) complaints at least once weekly despite 3.
✓. Signed online informed consent for participation in NL-CFT registry (the Netherlands Registry of invasive coronary vasomotor function testing), or willing to co-sign for registry at time of inclusion in EDIT-CAS
✕. Patients with limited life expectancy (\<1 year)
✕. Participation in another randomized clinical study with an use of an Investigational Medicinal Product (IMP) up to one month prior to enrolment.
✕. Pregnancy, active desire to become pregnant or unwilling to take adequate\* contraceptive measures when of child bearing potential for the duration of 6 months (active medication period + 3 months safety).
✕. Known heart failure with reduced ejection fraction\<35%