Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial (COIN)
Primary Purpose
Colchicine, Abdominal Aortic Aneurysm, Progression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
colchicine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Colchicine
Eligibility Criteria
Inclusion Criteria:
- 1. Aged over 55 and under 85; 2. Diagnosis of infrarenal abdominal aortic aneurysm within 3 months by CTA; 3. No indication for endovascular repair or surgery of abdominal aortic aneurysm
Exclusion Criteria:
- 1. Currently using colchicine; 2. Allergic to colchicine; 3. History of abdominal aortic aneurysm repair or surgery; 4. Combined with aortic dissection, thoracic aortic aneurysm, penetrating aortic ulcer (ulcer width>2cm and depth>1cm) and other aortic diseases requiring intervention; 5. Abdominal aortic aneurysm involving the renal artery or suprarenal abdominal aortic aneurysm; 6.Diameter of iliac aneurysm >29mm; 7. Renal artery stenosis or iliac artery stenosis planned for immediate intervention; 8. AAA caused by connective tissue disease (eg, collagen vascular disease), hereditary or genetic syndrome (eg, Marfan syndrome, Ehlers-Danlos syndrome); 9. Severe renal dysfunction (serum creatinine >176.8umol/L or eGFR <30ml/min) in the last 3 months 10. Severe liver dysfunction (ALT>2 ULN or TBIL>2 ULN)in the last 3 months; 11.Abnormal blood routine (hemoglobin <115g/L, white blood cell count<3.0×10^9/L, or platelet count <110×10^9/L) in the last 3 months; 12. Presence of inflammatory bowel disease or chronic diarrhea; 13. Current or planned usage of systemic immunosuppressants (eg, prednisone, azathioprine, methotrexate, cyclosporine for autoimmune disease or after bone marrow, heart, liver, lung, or other solid organ transplantation) ; 14.Patients with malignant tumors and autoimmune diseases; 15. Unable to take care of themselves, frail or expected survival time < 2 years; 16. Peripheral neuritis, myositis, or statin-related elevation of muscle enzymes; 17. Premenopausal, pregnant or lactating female patients; 18. Participated in other clinical studies of interventional therapy or drug therapy, which may interfere with the research results; 19. Refused or unable to sign informed consent to enter clinical research or to follow the research protocol and follow up.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
low-dose colchicine group
placebo group
Arm Description
colchicine 0.5mg per day for 24 months
placebo 0.5mg per day for 24 months
Outcomes
Primary Outcome Measures
changes of the maximum diameter of abdominal aortic aneurysm
the changes of the maximum diameter of abdominal aortic aneurysm on CTA in 24 months
Secondary Outcome Measures
changes of the maximum volume of abdominal aortic aneurysm
the changes of the maximum volume of abdominal aortic aneurysm on CTA in 24 months
aorta-related adverse events
rupture of abdominal aortic aneurysm, endovascular repair or surgery repair of abdominal aortic aneurysm,aortic-related death
major adverse cardiovascular events
cardiovascular death, acute coronary syndrome, interventon for coronary artery disease, ischemic stroke or transient ischemic attack
all-cause mortality
all-cause mortality
aortic-related mortality
aortic-related mortality
cardiovascular -related mortality
cardiovascular -related mortality
change of inflammatory biomarkers
change of CRP,D-dimer,MMP-9, IL-1β, IL-18
change of living quality
SF - 36 questionnaires
Full Information
NCT ID
NCT05361772
First Posted
April 30, 2022
Last Updated
April 30, 2022
Sponsor
Guangdong Provincial People's Hospital
Collaborators
The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, Peking University Shougang Hospital, Peking Union Medical College Hospital, The Second Xianya Hospital of Central South University, Zhongshan People's Hospital, Guangdong, China, Shenzhen Bao an People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05361772
Brief Title
Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial
Acronym
COIN
Official Title
Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2022 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial People's Hospital
Collaborators
The First Affiliated Hospital of Guangzhou Medical University, Shenzhen People's Hospital, Peking University Shougang Hospital, Peking Union Medical College Hospital, The Second Xianya Hospital of Central South University, Zhongshan People's Hospital, Guangdong, China, Shenzhen Bao an People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 (0.5 mg/d) 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 0.5 mg/d 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 1:1 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 (0.5 mg/d) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colchicine, Abdominal Aortic Aneurysm, Progression
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
230 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low-dose colchicine group
Arm Type
Experimental
Arm Description
colchicine 0.5mg per day for 24 months
Arm Title
placebo group
Arm Type
Placebo Comparator
Arm Description
placebo 0.5mg per day for 24 months
Intervention Type
Drug
Intervention Name(s)
colchicine
Intervention Description
colchicine 0.5mg per day for 24 months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo 0.5mg per day for 24 months
Primary Outcome Measure Information:
Title
changes of the maximum diameter of abdominal aortic aneurysm
Description
the changes of the maximum diameter of abdominal aortic aneurysm on CTA in 24 months
Time Frame
24 months
Secondary Outcome Measure Information:
Title
changes of the maximum volume of abdominal aortic aneurysm
Description
the changes of the maximum volume of abdominal aortic aneurysm on CTA in 24 months
Time Frame
24 months
Title
aorta-related adverse events
Description
rupture of abdominal aortic aneurysm, endovascular repair or surgery repair of abdominal aortic aneurysm,aortic-related death
Time Frame
24 months
Title
major adverse cardiovascular events
Description
cardiovascular death, acute coronary syndrome, interventon for coronary artery disease, ischemic stroke or transient ischemic attack
Time Frame
24 months
Title
all-cause mortality
Description
all-cause mortality
Time Frame
24 months
Title
aortic-related mortality
Description
aortic-related mortality
Time Frame
24 months
Title
cardiovascular -related mortality
Description
cardiovascular -related mortality
Time Frame
24 months
Title
change of inflammatory biomarkers
Description
change of CRP,D-dimer,MMP-9, IL-1β, IL-18
Time Frame
24 months
Title
change of living quality
Description
SF - 36 questionnaires
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Aged over 55 and under 85; 2. Diagnosis of infrarenal abdominal aortic aneurysm within 3 months by CTA; 3. No indication for endovascular repair or surgery of abdominal aortic aneurysm
Exclusion Criteria:
1. Currently using colchicine; 2. Allergic to colchicine; 3. History of abdominal aortic aneurysm repair or surgery; 4. Combined with aortic dissection, thoracic aortic aneurysm, penetrating aortic ulcer (ulcer width>2cm and depth>1cm) and other aortic diseases requiring intervention; 5. Abdominal aortic aneurysm involving the renal artery or suprarenal abdominal aortic aneurysm; 6.Diameter of iliac aneurysm >29mm; 7. Renal artery stenosis or iliac artery stenosis planned for immediate intervention; 8. AAA caused by connective tissue disease (eg, collagen vascular disease), hereditary or genetic syndrome (eg, Marfan syndrome, Ehlers-Danlos syndrome); 9. Severe renal dysfunction (serum creatinine >176.8umol/L or eGFR <30ml/min) in the last 3 months 10. Severe liver dysfunction (ALT>2 ULN or TBIL>2 ULN)in the last 3 months; 11.Abnormal blood routine (hemoglobin <115g/L, white blood cell count<3.0×10^9/L, or platelet count <110×10^9/L) in the last 3 months; 12. Presence of inflammatory bowel disease or chronic diarrhea; 13. Current or planned usage of systemic immunosuppressants (eg, prednisone, azathioprine, methotrexate, cyclosporine for autoimmune disease or after bone marrow, heart, liver, lung, or other solid organ transplantation) ; 14.Patients with malignant tumors and autoimmune diseases; 15. Unable to take care of themselves, frail or expected survival time < 2 years; 16. Peripheral neuritis, myositis, or statin-related elevation of muscle enzymes; 17. Premenopausal, pregnant or lactating female patients; 18. Participated in other clinical studies of interventional therapy or drug therapy, which may interfere with the research results; 19. Refused or unable to sign informed consent to enter clinical research or to follow the research protocol and follow up.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Songyuan Luo, MD
Phone
+86-13570337597
Email
656781257@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guokui Zhang, MM
Phone
+86-13622266656
Email
772379801@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianfang Luo, MD
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial
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