Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial

Abdominal Aortic Aneurysm Clinical Trial

— COIN  

Official title:

Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05361772
• Other study ID #: KY-N-2022-027-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: Guangdong Provincial People's Hospital
• Contact: Songyuan Luo, MD
• Phone: +86-13570337597
• Email: 656781257[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 230
• Est. completion date: December 31, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal
• Colchicine
• Progression

Intervention

Drug:
• colchicine
colchicine 0.5mg per day for 24 months
• Placebo
placebo 0.5mg per day for 24 months

Locations

Country	Name	City	State
n/a

Sponsors (8)

Lead Sponsor	Collaborator
Guangdong Provincial People's Hospital	Peking Union Medical College Hospital, Peking University Shougang Hospital, Shenzhen Bao an People's Hospital, Shenzhen People's Hospital, The First Affiliated Hospital of Guangzhou Medical University, The Second Xianya Hospital of Central South University, Zhongshan People's Hospital, Guangdong, China

References & Publications (12)

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* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of the maximum diameter of abdominal aortic aneurysm	the changes of the maximum diameter of abdominal aortic aneurysm on CTA in 24 months	24 months
Secondary	changes of the maximum volume of abdominal aortic aneurysm	the changes of the maximum volume of abdominal aortic aneurysm on CTA in 24 months	24 months
Secondary	aorta-related adverse events	rupture of abdominal aortic aneurysm, endovascular repair or surgery repair of abdominal aortic aneurysm,aortic-related death	24 months
Secondary	major adverse cardiovascular events	cardiovascular death, acute coronary syndrome, interventon for coronary artery disease, ischemic stroke or transient ischemic attack	24 months
Secondary	all-cause mortality	all-cause mortality	24 months
Secondary	aortic-related mortality	aortic-related mortality	24 months
Secondary	cardiovascular -related mortality	cardiovascular -related mortality	24 months
Secondary	change of inflammatory biomarkers	change of CRP,D-dimer,MMP-9, IL-1ß, IL-18	24 months
Secondary	change of living quality	SF - 36 questionnaires	24 months