Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial

Launched by GUANGDONG PROVINCIAL PEOPLE'S HOSPITAL · Apr 30, 2022

Keywords

ClinConnect Summary

The Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial, also known as the COIN trial, is a research study that aims to find out if a low dose of colchicine, a medication, can help slow down the growth of small abdominal aortic aneurysms (AAA). An abdominal aortic aneurysm is a bulge in the main blood vessel that supplies blood to the body, and if it grows too large, it can be dangerous. In this study, about 230 participants aged between 55 and 85 who have recently been diagnosed with a small AAA will be randomly assigned to receive either the colchicine or a placebo (a non-active pill) for comparison.

Participants in the trial will visit the clinic every three months for follow-ups and will undergo special imaging tests after two years to check on the size and volume of the aneurysm. To be eligible for the study, individuals must not have any other serious health issues, such as requiring surgery for their aneurysm, and they should not be currently taking colchicine or have allergies to it. This trial is not yet recruiting, but it hopes to provide valuable information on whether colchicine can make a difference in managing AAA growth and related health risks.

Gender

ALL

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.