Ignite Creation Date:
2024-07-17 @ 10:59 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06472908
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-25
First Post:
2024-06-19
Brief Title:
Efficacy and Safety of Colchicine After PCI
Sponsor:
Wuhan Union Hospital China
Organization:
Wuhan Union Hospital China
Study Overview
Official Title:
Efficacy and Safety of Colchicine After Percutaneous Coronary Intervention
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:
Colchicine 05 mgday was recommended by the US Food and Drug Administration in 2023 for the anti-inflammatory treatment of coronary heart disease CHD However colchicine is still not approved for CHD treatment in China There is no large-scale clinical evidence that colchicine can be used to treat Chinese patients with CHD Considering the low body weight of the East Asian population it is unclear whether the recommended standard dose 05 mgday is suitable for Chinese patients Therefore we need to further explore the effects of different doses of colchicine on the efficacy and safety of clinical endpoints in the Chinese population with CHD
This study is a multicenter prospective randomized controlled double-blind event-driven clinical study conducted in China The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population
This study is a multicenter prospective randomized controlled double-blind event-driven clinical study conducted in China The primary objective of this study is to determine whether long-term treatment with different doses of colchicine reduces the incidence of cardiovascular events in Chinese patients undergoing PCI The secondary objective is to determine the safety of long-term treatment with different doses of colchicine in this patient population
Detailed Description:
After informed consent 8862 subjects who meet all inclusion will be randomly assigned to receive colchicine 05 mgday colchicine 0375 mgday or placebo 111 allocation ratio with follow-up at months 1 6 12 18 24 after randomization and phone assessments at months 3 9 15 21 The occurrence of any endpoints or other adverse events will be assessed every 3 months Subjects will also receive standard medical care for antiplatelets control of dyslipidemia hypertension angina and diabetes as directed by national guidelines All suspected cardiovascular endpoints will be adjudicated by the Clinical Event Committee CEC consisting of three experienced members blinded as to allocation of therapy The Data and Safety Monitoring Board DSMB consisting of five fully independent members will review unblinded safety data as detailed in the DSMB charter An interim analysis is planned after approximately 50 of primary endpoints have been positively adjudicated The DSMB charter will pre-specify the methodology for the interim analysis and the rules for early termination of the study
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