Ignite Creation Date:
2024-05-06 @ 7:59 PM
Last Modification Date:
2024-10-26 @ 3:18 PM
Study NCT ID:
NCT06215989
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-01-11
Brief Title:
Treatment of ACuTe Coronary Syndromes With Low-dose colchICine
Sponsor:
Beijing Anzhen Hospital
Organization:
Beijing Anzhen Hospital
Study Overview
Official Title:
Treatment of ACuTe Coronary Syndromes With Low-dose colchICine TACTIC a Randomised Double-blinded Placebo-controlled Multicentric Trial
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:
None
Brief Summary:
This trial is designed to evaluate whether low-dose colchicine in addition to standard treatment recommended by guidelines further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes ACS through a prospective randomized double-blind placebo-controlled clinical trial
Detailed Description:
Background Colchicine is a cheap and potent oral anti-inflammatory drug that can exert its anti-inflammatory effect on the pathogenesis of ACS The 2023 updated guidelines for the management of chronic stable coronary artery disease SCAD by the American Heart Association AHAAmerican College of Cardiology ACC have identified colchicine as the drug of choice for secondary preventive treatment in patients with SCAD to reduce the risk of recurrence of adverse cardiovascular events Despite the current optimal medical therapies some ACS patients still suffer recurrent adverse cardiovascular events and mortality Existing clinical studies have not fully clarified whether early use of colchicine to reduce inflammatory responses is associated with greater clinical benefit after ACS The effect of colchicine on cardiovascular outcomes in the ACS patients needs further elucidation
Methods Patients aged 18 years and older with a definite diagnosis of ACS are randomly assigned to two groups in a 11 ratio after signing the informed consent form Colchicine group standard treatment colchicine 05mg qd from 1st month to 12th month after randomization Placebo group standard treatment placebo 1 tablet qd from 1st month to 12th month after randomization The primary endpoint is the composite of cardiovascular death non-fatal ischemic stroke non-fatal spontaneous non-operation related myocardial infarction readmission for ACS and ischaemia driven unplanned revascularization at 1 year after randomization
Methods Patients aged 18 years and older with a definite diagnosis of ACS are randomly assigned to two groups in a 11 ratio after signing the informed consent form Colchicine group standard treatment colchicine 05mg qd from 1st month to 12th month after randomization Placebo group standard treatment placebo 1 tablet qd from 1st month to 12th month after randomization The primary endpoint is the composite of cardiovascular death non-fatal ischemic stroke non-fatal spontaneous non-operation related myocardial infarction readmission for ACS and ischaemia driven unplanned revascularization at 1 year after randomization
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