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Enrolling by invitation NCT06432452

Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm

Phase II / Phase III Interventional Coronary Spasm

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Endothelin Receptor Antagonist, Placebo control.
Who it may be relevant to
Registry conditions: Coronary Spasm. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug Endothelin Receptor Antagonist
    Oral capsules twice daily
  • Other Placebo control
    Oral capsules twice daily

Primary outcome measures

  • Successful treatment [Time frame: 10 weeks]
Secondary outcome measures (1)
  • Improvement of anginal complaints [Time frame: 10 weeks]

Eligibility criteria

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
  • Written informed consent for EDIT-CAS

Exclusion criteria

  • Systolic blood pressure (SBP) <85 mmHg measured at Visit 1
  • Significant hepatic impairment at time of iCFT lab (ASAT/ALAT >3x upper limit of normal (ULN)) or history of liver cirrhosis (Child-Pugh 7-15)
  • Severe anemia (Hb<6.0mmol/L) without identified cause at time of inclusion
  • 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%
  • Known pulmonary hypertension of any type
  • Potentially dangerous interaction due to the use of another CYP3A4 or CYP2C9 substrate (e.g. ciclosporin A, glibenclamide, fluconazole, rifampicin, tacrolimus/sirolimus, lopinavir/ritonavir)
  • Repeat spasm provocation test deemed unsafe (e.g. allergic reaction at iCFT)
  • Adequate in this case meaning if on hormonal contraceptives, additional measures to be taken (e.g. condom).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

Netherlands · 4 centers
  • Catharina Ziekenhuis — Eindhoven
  • Maasstad Hospital — Rotterdam
  • RadboudUMC — Nijmegen
  • UMC Utrecht — Utrecht

Publications

  • 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. Design and rationale of the efficacy of endothelin receptor antagonism in treatment of coronary artery spasm: a randomized controlled trial (EDIT-CAS). Am Heart J. 2025 Oct;288:140-148. doi: 10.1016/j.ahj. PMID 40274007

Identifiers

NCT: NCT06432452 · 114746

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗