NCT05361772

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
230

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2022

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 5, 2022

Completed
27 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2024

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

May 5, 2022

Status Verified

April 1, 2022

Enrollment Period

2 years

First QC Date

April 30, 2022

Last Update Submit

April 30, 2022

Conditions

ColchicineAbdominal Aortic AneurysmProgression

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • changes of the maximum volume of abdominal aortic aneurysm

    24 months

  • aorta-related adverse events

    24 months

  • major adverse cardiovascular events

    24 months

  • all-cause mortality

    24 months

  • aortic-related mortality

    24 months

  • +3 more secondary outcomes

Study Arms (2)

low-dose colchicine group

EXPERIMENTAL

colchicine 0.5mg per day for 24 months

Drug: colchicine

placebo group

PLACEBO COMPARATOR

placebo 0.5mg per day for 24 months

Drug: Placebo

Interventions

colchicineDRUG

colchicine 0.5mg per day for 24 months

low-dose colchicine group
PlaceboDRUG

placebo 0.5mg per day for 24 months

placebo group

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \. 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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • Sakalihasan N, Michel JB, Katsargyris A, Kuivaniemi H, Defraigne JO, Nchimi A, Powell JT, Yoshimura K, Hultgren R. Abdominal aortic aneurysms. Nat Rev Dis Primers. 2018 Oct 18;4(1):34. doi: 10.1038/s41572-018-0030-7.

    PMID: 30337540BACKGROUND

  • Li W, Luo S, Luo J, Liu Y, Ning B, Huang W, Xue L, Chen J. Predictors Associated With Increased Prevalence of Abdominal Aortic Aneurysm in Chinese Patients with Atherosclerotic Risk Factors. Eur J Vasc Endovasc Surg. 2017 Jul;54(1):43-49. doi: 10.1016/j.ejvs.2017.04.004. Epub 2017 May 17.

    PMID: 28527818BACKGROUND

  • Guirguis-Blake JM, Beil TL, Senger CA, Coppola EL. Primary Care Screening for Abdominal Aortic Aneurysm: Updated Evidence Report and Systematic Review for the US Preventive Services Task Force. JAMA. 2019 Dec 10;322(22):2219-2238. doi: 10.1001/jama.2019.17021.

    PMID: 31821436BACKGROUND

  • Kuivaniemi H, Elmore JR. Opportunities in abdominal aortic aneurysm research: epidemiology, genetics, and pathophysiology. Ann Vasc Surg. 2012 Aug;26(6):862-70. doi: 10.1016/j.avsg.2012.02.005.

    PMID: 22794334BACKGROUND

  • Umebayashi R, Uchida HA, Wada J. Abdominal aortic aneurysm in aged population. Aging (Albany NY). 2018 Dec 6;10(12):3650-3651. doi: 10.18632/aging.101702. No abstract available.

    PMID: 30523221BACKGROUND

  • Liu CL, Ren J, Wang Y, Zhang X, Sukhova GK, Liao M, Santos M, Luo S, Yang D, Xia M, Inouye K, Hotamisligil GS, Lu G, Upchurch GR, Libby P, Guo J, Zhang J, Shi GP. Adipocytes promote interleukin-18 binding to its receptors during abdominal aortic aneurysm formation in mice. Eur Heart J. 2020 Jul 7;41(26):2456-2468. doi: 10.1093/eurheartj/ehz856.

    PMID: 31821481BACKGROUND

  • Golledge J. Abdominal aortic aneurysm: update on pathogenesis and medical treatments. Nat Rev Cardiol. 2019 Apr;16(4):225-242. doi: 10.1038/s41569-018-0114-9.

    PMID: 30443031BACKGROUND

  • Oliver-Williams C, Sweeting MJ, Jacomelli J, Summers L, Stevenson A, Lees T, Earnshaw JJ. Safety of Men With Small and Medium Abdominal Aortic Aneurysms Under Surveillance in the NAAASP. Circulation. 2019 Mar 12;139(11):1371-1380. doi: 10.1161/CIRCULATIONAHA.118.036966.

    PMID: 30636430BACKGROUND

  • Freiberg MS, Arnold AM, Newman AB, Edwards MS, Kraemer KL, Kuller LH. Abdominal aortic aneurysms, increasing infrarenal aortic diameter, and risk of total mortality and incident cardiovascular disease events: 10-year follow-up data from the Cardiovascular Health Study. Circulation. 2008 Feb 26;117(8):1010-7. doi: 10.1161/CIRCULATIONAHA.107.720219. Epub 2008 Feb 11.

    PMID: 18268154BACKGROUND

  • Forsythe RO, Dweck MR, McBride OMB, Vesey AT, Semple SI, Shah ASV, Adamson PD, Wallace WA, Kaczynski J, Ho W, van Beek EJR, Gray CD, Fletcher A, Lucatelli C, Marin A, Burns P, Tambyraja A, Chalmers RTA, Weir G, Mitchard N, Tavares A, Robson JMJ, Newby DE. 18F-Sodium Fluoride Uptake in Abdominal Aortic Aneurysms: The SoFIA3 Study. J Am Coll Cardiol. 2018 Feb 6;71(5):513-523. doi: 10.1016/j.jacc.2017.11.053.

    PMID: 29406857BACKGROUND

  • MA3RS Study Investigators. Aortic Wall Inflammation Predicts Abdominal Aortic Aneurysm Expansion, Rupture, and Need for Surgical Repair. Circulation. 2017 Aug 29;136(9):787-797. doi: 10.1161/CIRCULATIONAHA.117.028433. Epub 2017 Jul 18.

    PMID: 28720724BACKGROUND

  • Vainas T, Lubbers T, Stassen FR, Herngreen SB, van Dieijen-Visser MP, Bruggeman CA, Kitslaar PJ, Schurink GW. Serum C-reactive protein level is associated with abdominal aortic aneurysm size and may be produced by aneurysmal tissue. Circulation. 2003 Mar 4;107(8):1103-5. doi: 10.1161/01.cir.0000059938.95404.92.

    PMID: 12615785BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalDisease Progression

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlkaloidsHeterocyclic Compounds

Study Officials

  • Jianfang Luo, MD

    Guangdong Provincial People's Hospital

    STUDY CHAIR

Central Study Contacts

Songyuan Luo, MD

CONTACT

+86-13570337597656781257@qq.com

Guokui Zhang, MM

CONTACT

+86-13622266656772379801@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

April 30, 2022

First Posted

May 5, 2022

Study Start

June 1, 2022

Primary Completion

June 1, 2024

Study Completion

December 31, 2025

Last Updated

May 5, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share