Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432452
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-10
Brief Title:
Efficacy of Endothelin Receptor Antagonism in Coronary Artery Spasm
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Efficacy of Endothelin Receptor Antagonism in Treatment of Coronary Artery Spasm a Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EDIT-CAS
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None