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Efficacy of endothelin receptor antagonism in treatment of coronary artery spasm: a randomized controlled clinical trial. (EDIT-CAS)
EU CTIS ID: 2023-507782-25-00
What this study is testing
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.
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 antianginal medicines i.e. nitrate and calcium channel blocker)
- 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
You likely can't join if
- 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)
See the full eligibility 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 antianginal medicines i.e. nitrate and calcium channel blocker)
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.