Status:
UNKNOWN
Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial
Lead Sponsor:
Guangdong Provincial People's Hospital
Collaborating Sponsors:
The First Affiliated Hospital of Guangzhou Medical University
Shenzhen People's Hospital
Conditions:
Colchicine
Abdominal Aortic Aneurysm
Eligibility:
All Genders
55-85 years
Phase:
NA
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 allocat...
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 A...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT05361772
Start Date
June 1 2022
End Date
December 31 2025
Last Update
May 5 2022
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