Clinical Trial

Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

Study acronym: EDIT-CAS
Enrolling by Invitation Phase 2/3
View on ClinicalTrials.gov →
Record status
This record was last updated November 18, 2024 (before its estimated June 15, 2026 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-05-21.
Status change: Not Yet Recruiting → Enrolling by Invitation 2024-11-14
Trial Details
NCT Number NCT06432452
Lead Sponsor Radboud University Medical Center
Collaborators: UMC Utrecht, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
Conditions Coronary Spasm
Enrollment 100 participants
Start Date 2024-11-11
Primary Completion 2026-06-15 (estimated)
Study Completion 2026-07-01 (estimated)
Updated on ClinicalTrials.gov 2024-11-18