Efficacy of endothelin receptor antagonism in treatment of coronary artery spasm: a randomized controlled clinical trial. (EDIT-CAS)

Phase 1

• Conditions: Coronary vasomotor dysfunction (spasm), Coronary vasospasm; MedDRA version: 20.0Level: LLTClassification code: 10011110Term: Coronary vasospasm Class: 10007541; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: CTIS2023-507782-25-00
• Lead Sponsor: Stichting Radboud University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-07
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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 (meaning at least 1 daily anti-anginal medicine since at least 4 weeks), Continuing episodes of angina(-like) complaints at least once weekly despite optimal regular care, Signed online informed consent for participation in NL-CFT registry, 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) <85mmHg measured at Visit 1, Potentially dangerous interaction due to the use of another CYP3A4 or CYP2C9 substrate (see appendix A: ciclosporin A, glibenclamide, fluconazole, rifampicine, tacrolimus/sirolimus, lopinavir/ritonavir), Repeat spasm provocation test deemed unsafe (e.g. allergic reaction at iCFT), 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified