Ignite Creation Date:
2024-05-06 @ 5:36 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05361772
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-05-05
First Post:
2022-04-30
Brief Title:
Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-04
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:
COIN
Brief Summary:
COIN trial is a a prospective randomized placebo-controlled double-blind multicenter clinical study Approximately 230 patients with small abdominal aortic aneurysms AAA will be randomly allocated to low-dose colchicine group or placebo group All study patients will be followed up in the outpatient clinic every 3 months and undergo CTA scans after 24 months from randomization The primary objective is to test the hypothesis that low dose colchicine can inhibit the progression of AAA diameter The secondary objective is to test the hypothesis that low dose colchicine can inhibit the progression of AAA volume reduce the incidence of clinical outcomes associated with AAA reduce the incidence of major adverse cardiovascular events and all-cause mortality
Detailed Description:
This study is a prospective randomized placebo-controlled double-blind multicenter clinical study to test the research hypothesis that low-dose colchicine 05 mgd can delay the progression of AAA
The study will enroll patients with infrarenal abdominal aortic aneurysms with a maximum diameter of 30-50 mm and no indication for surgical or endovascular treatment All patients will receive the best standard medical treatment Before randomization all patients will undergo a 1-month lead-in period during which open-label colchicine 05 mgd will be administered If there is colchicine intolerance they will not be randomized
The study center performed computer-generated block randomization block size 8 Randomization method and block size will not unblinded until all data analyses are completed Enrolled patients will randomly assigned to each hospital in a 11 ratio by the randomization center through sequentially coded sealed light-tight envelopes to colchicine and placebo groups
After randomization patients will receive low-dose colchicine 05 mgd or placebo respectively and will be followed up for 24 months We will evulate whether low-dose colchicine can delay the progression of AAA by assessing the change in maximum aneurysm diameter by CTA At the same time its effects on abdominal aortic aneurysm-related and cardiovascular-related clinical events will be observed
The study will enroll patients with infrarenal abdominal aortic aneurysms with a maximum diameter of 30-50 mm and no indication for surgical or endovascular treatment All patients will receive the best standard medical treatment Before randomization all patients will undergo a 1-month lead-in period during which open-label colchicine 05 mgd will be administered If there is colchicine intolerance they will not be randomized
The study center performed computer-generated block randomization block size 8 Randomization method and block size will not unblinded until all data analyses are completed Enrolled patients will randomly assigned to each hospital in a 11 ratio by the randomization center through sequentially coded sealed light-tight envelopes to colchicine and placebo groups
After randomization patients will receive low-dose colchicine 05 mgd or placebo respectively and will be followed up for 24 months We will evulate whether low-dose colchicine can delay the progression of AAA by assessing the change in maximum aneurysm diameter by CTA At the same time its effects on abdominal aortic aneurysm-related and cardiovascular-related clinical events will be observed
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