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Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

Study acronym: EDIT-CAS
StatusEnrolling by Invitation
PhasePhase 2/3
Started
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.

Record History

  1. Trial status: Not Yet Recruiting to Enrolling by Invitationv2 Show 4 more changesShow less
    • Start date changed from estimate of Aug 1, 2024 to Nov 11, 2024
    • Primary completion date: Jan 15, 2026 to Jun 15, 2026
    • Study completion date: Apr 1, 2026 to Jul 1, 2026
    • Site contacts updated at 4 of 4 sites
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT06432452
Lead Sponsor Radboud University Medical Center
Collaborators: UMC Utrecht, Catharina Ziekenhuis Eindhoven, Maasstad Hospital
Conditions
(from sponsor)		 Coronary Spasm
Related terms Angina Pectoris, Angina Pectoris, Variant
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov