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Low-dose Colchicine Inhibit Abdominal Aortic Aneurysm Growth Trial

NCT05361772 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2022-05-05

No results posted yet for this study

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.

Conditions

  • Colchicine
  • Abdominal Aortic Aneurysm
  • Progression

Interventions

DRUG

colchicine

colchicine 0.5mg per day for 24 months

DRUG

Placebo

placebo 0.5mg per day for 24 months

Sponsors & Collaborators

  • The First Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER

  • Shenzhen People's Hospital

    collaborator OTHER

  • Peking University Shougang Hospital

    collaborator OTHER

  • Peking Union Medical College Hospital

    collaborator OTHER

  • Second Xiangya Hospital of Central South University

    collaborator OTHER

  • Zhongshan People's Hospital, Guangdong, China

    collaborator OTHER

  • Shenzhen Bao an People's Hospital

    collaborator UNKNOWN

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Jianfang Luo, MD · Guangdong Provincial People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
55 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-01
Primary Completion
2024-06-01
Completion
2025-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361772 on ClinicalTrials.gov