Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:11 PM
Study NCT ID:
NCT06095765
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2023-09-25
Brief Title:
Colchicine in Belgium in Patients With Coronary Artery Disease After Percutaneous Coronary Intervention
Sponsor:
AZ Sint-Jan AV
Organization:
AZ Sint-Jan AV
Study Overview
Official Title:
Colchicine in Belgium in Patients With Coronary Artery Disease
Status:
RECRUITING
Status Verified Date:
2024-03
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:
COL BE PCI
Brief Summary:
The main aim of this trial is to determine whether there are fewer cardiovascular events when patients with coronary artery disease take a low dose of colchicine of 05 mg daily on top of optimal standard treatment after treatment with PCI compared with placebo in combination with optimal standard treatment More specifically we aim to investigate the benefits of a daily low dose of colchicine in patients with coronary artery disease after treatment with PCI to confirm that a daily low dose of colchicine helps prevent additional incidents in coronary artery disease and to identify a subgroup of patients with CAD who are at increased risk for cardiovascular events and could benefit most from colchicine
Detailed Description:
This is a prospective randomised double-blind multicenter placebo-controlled phase III pragmatic superiority trial comparing colchicine 05 mg with placebo administered orally once-daily in up to 2770 participants with CAD treated with PCI Participants will be randomised in a 11 ratio to receive either colchicine 05 mg or placebo as an adjunct to standard of care The trial is event driven with trial closure being performed when the targeted number of 566 primary endpoint events has been reached
Participants will be seen by the site staff 1 month after randomisation and thereafter every 12 months as per standard of care SOC and for IMP dispense and compliance completing questionnaires and outcome event assessment until end of study After the first month a telephone visit will be scheduled every 6 months in between two standard of care on-site visits
Participants will be seen by the site staff 1 month after randomisation and thereafter every 12 months as per standard of care SOC and for IMP dispense and compliance completing questionnaires and outcome event assessment until end of study After the first month a telephone visit will be scheduled every 6 months in between two standard of care on-site visits
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-505028-74-00 | OTHER | EU CT number | None |
| KCE-INV-21-1324 | OTHER_GRANT | None | None |