Ignite Creation Date:
2024-05-06 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 2:28 PM
Study NCT ID:
NCT05294887
Status:
UNKNOWN
Last Update Posted:
2022-03-24
First Post:
2022-02-28
Brief Title:
Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease
Sponsor:
Charite University Berlin Germany
Organization:
Charite University Berlin Germany
Study Overview
Official Title:
First Prospective Randomized Trial to Examine a Differential Therapeutic Response in Symptomatic Patients With Non-obstructive Coronary Artery Disease After Coronary Physiological Testing
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
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:
EXAMINE-CAD
Brief Summary:
EXAMINE-CAD-DZHK22 is a prospective randomized double-blind placebo-controlled crossover trial investigating the efficacy of beta blocker bisoprolol and calcium channel blocker diltiazem therapy in symptomatic patients with non-obstructed coronary arteries according to coronary physiological testing results
Detailed Description:
Patients presenting with recurrent angina but non-obstructed coronary arteries are increasingly recognized and have a high morbidity and symptomatic burden These patients are often misdiagnosed and discharged without further investigation or treatment Current European Society of Cardiology ESC guidelines for the management of patients with chronic coronary syndromes recommend beta blockers or calcium channel blockers depending on the presence of abnormal vasodilatation or abnormal vasoconstriction Scientific evidence to support this recommendation however is scarce and no randomized clinical trial of this differential therapy has been performed in these patients The aim of the EXAMINE-CAD-DZHK22 trial is therefore to compare for the first time the efficacy of beta blocker bisoprolol and calcium channel blocker diltiazem therapy in reducing angina symptoms in symptomatic patients with non-obstructed coronary arteries according to coronary physiology testing results This study is the first to investigate whether coronary physiology testing can guide therapeutic management of these patients depending on whether abnormalities of vasodilatation or vasoconstriction are present The EXAMINE-CAD-DZHK22 trial will thus fill an important knowledge and evidence gap in the treatment of these highly symptomatic patients and has the potential to pave the way for future large-scale clinical trials in symptomatic patients with non-obstructed coronary arteries
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2020-004717-12 | EUDRACT_NUMBER | None | None |