Ignite Creation Date:
2024-07-17 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469528
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-06-10
Brief Title:
ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes
Sponsor:
Kings College Hospital NHS Trust
Organization:
Kings College Hospital NHS Trust
Study Overview
Official Title:
ESCALATion of Medical Therapy Following Multimodality Plaque Evaluation in High-risk Chronic Coronary Syndromes
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
ESCALATE
Brief Summary:
ESCALATE will provide a thorough investigation of how anti-inflammatory therapy with low-dose colchicine affects patients with stable coronary artery disease Using traditional clinical risk factors and multimodality intracoronary imaging the investigators will identify patients with the greatest clinical risk
Participants will undergo repeat multimodality intracoronary imaging assessment at 6 months to measure the impact once-daily low-dose colchicine therapy on the structure and function of coronary arteries
This study will provide valuable insights into how anti-inflammatory therapies such as colchicine may improve outcomes in patients with coronary artery disease
Participants will undergo repeat multimodality intracoronary imaging assessment at 6 months to measure the impact once-daily low-dose colchicine therapy on the structure and function of coronary arteries
This study will provide valuable insights into how anti-inflammatory therapies such as colchicine may improve outcomes in patients with coronary artery disease
Detailed Description:
1 Background and study aims
Despite recent advances coronary artery disease CAD remains the main cause of death worldwide CAD occurs when the arteries bringing blood to the heart become narrowed by a build-up of fatty material within their walls If this occurs gradually it can cause chest discomfort ie angina In a heart attack the artery wall becomes inflamed and splits causing blood clot formation and an abrupt blockage of flow resulting in severe pain and damaged heart muscle
Current treatments focus on reducing cholesterol slowing the build-up of fatty material and rapidly restoring blood flow during a heart attack Chronic inflammation acting in tandem with other risk factors has been identified as playing a central role in CAD progression and its acute manifestations
Colchicine is a safe well-tolerated anti-inflammatory therapy used in the treatment of gout and other inflammatory conditions Daily treatment with low-dose colchicine has proven effective in reducing rates of heart attack and death in large clinical trials but use in routine practice remains low A contributing factor to this reticence is uncertainty regarding the mechanism through which colchicine provides benefit This study is designed to address this knowledge gap
2 Who can participate
Patients aged 18 to 90 years old with coronary artery disease and high clinical risk
3 What does the study involve
Using traditional markers of clinical risk and state-of-the-art imaging from inside the coronary artery the researchers will identify patients with CAD and the greatest clinical risk Eligible patients already established on statin therapy will be allocated to a six-month course of low-dose colchicine plus usual care or usual care only Researchers participants and usual clinicians will be aware of the allocation during the study
After 6 months the researchers will assess the impact of colchicine on the appearance of individual coronary artery lesions blood flow in the large and small blood vessels of the heart This study will provide a detailed assessment of colchicine and its mechanism of action in CAD
Despite recent advances coronary artery disease CAD remains the main cause of death worldwide CAD occurs when the arteries bringing blood to the heart become narrowed by a build-up of fatty material within their walls If this occurs gradually it can cause chest discomfort ie angina In a heart attack the artery wall becomes inflamed and splits causing blood clot formation and an abrupt blockage of flow resulting in severe pain and damaged heart muscle
Current treatments focus on reducing cholesterol slowing the build-up of fatty material and rapidly restoring blood flow during a heart attack Chronic inflammation acting in tandem with other risk factors has been identified as playing a central role in CAD progression and its acute manifestations
Colchicine is a safe well-tolerated anti-inflammatory therapy used in the treatment of gout and other inflammatory conditions Daily treatment with low-dose colchicine has proven effective in reducing rates of heart attack and death in large clinical trials but use in routine practice remains low A contributing factor to this reticence is uncertainty regarding the mechanism through which colchicine provides benefit This study is designed to address this knowledge gap
2 Who can participate
Patients aged 18 to 90 years old with coronary artery disease and high clinical risk
3 What does the study involve
Using traditional markers of clinical risk and state-of-the-art imaging from inside the coronary artery the researchers will identify patients with CAD and the greatest clinical risk Eligible patients already established on statin therapy will be allocated to a six-month course of low-dose colchicine plus usual care or usual care only Researchers participants and usual clinicians will be aware of the allocation during the study
After 6 months the researchers will assess the impact of colchicine on the appearance of individual coronary artery lesions blood flow in the large and small blood vessels of the heart This study will provide a detailed assessment of colchicine and its mechanism of action in CAD
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