Ignite Creation Date:
2024-05-06 @ 5:16 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05250596
Status:
COMPLETED
Last Update Posted:
2023-03-08
First Post:
2022-02-08
Brief Title:
COLchicine On-admission to Reduce Inflammation in Acute Coronary Syndrome COLOR-ACS
Sponsor:
Azienda USL Toscana Centro
Organization:
Azienda USL Toscana Centro
Study Overview
Official Title:
On-admission Low-dose Colchicine in Addition to Atorvastatin to Reduce Inflammation in Acute Coronary Syndrome
Status:
COMPLETED
Status Verified Date:
2024-07
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:
COLOR-ACS
Brief Summary:
Since colchicine is known to have anti-inflammatory effects and inflammation is an early component of acute coronary syndrome ACS this study aims to evaluate the acute effects of low-dose colchicine in addition to atorvastatin administered on-admission to statin-naive patients with non-ST elevation ACS scheduled for early invasive strategy
Detailed Description:
On-admission all statin naive NSTEACS patients are randomized to receive either standard treatment of atorvastatin 80 mg or standard treatment plus colchicine 1 mg loading dose followed by 05 mgday
Inflammatory biomarker high sensitivity C reactive protein hs-CRP is measured in all patients on-admission and every 24 hours thereafter until discharge
Cardiac and renal function parameters are evaluated to evidence the possible beneficial effects of the administration of colchicine in addition to atorvastatin alone both short- and medium-term up to 30 days
Colchicine tolerance is also investigated through monitoring for clinical side effects
Inflammatory biomarker high sensitivity C reactive protein hs-CRP is measured in all patients on-admission and every 24 hours thereafter until discharge
Cardiac and renal function parameters are evaluated to evidence the possible beneficial effects of the administration of colchicine in addition to atorvastatin alone both short- and medium-term up to 30 days
Colchicine tolerance is also investigated through monitoring for clinical side effects
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 |
|---|---|---|---|
| 2021-000637-13 | EUDRACT_NUMBER | None | None |