NCT06432452

Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

Efficacy of Endothelin Receptor Antagonism in Treatment of Coronary Artery Spasm: a Randomized Controlled Clinical Trial

• Status: Enrolling By Invitation
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Radboud University Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Coronary Spasm

Interventions

Type	Name	Description
DRUG	Endothelin Receptor Antagonist	Oral capsules twice daily
OTHER	Placebo control	Oral capsules twice daily

Timeline

• Start date: 2024-11-11
• Primary completion: 2026-06-15
• Completion: 2026-07-01
• First posted: 2024-05-29
• Last updated: 2024-11-18

Locations

4 sites across 1 country: Netherlands