Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

NCT06025071 | Unknown Phase 4 DMC

• 1 other identifier: 2023-GSP-GG-40
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no specific intervention in selected elderly patients (60-80 years old) with residual inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions it aims to answer are:

• Whether the intervention is effective in reducing ischemic events
• Whether the intervention is effective in reducing inflammatory biomarkers' level
• Whether the intervention is safe for elderly patients Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no specific intervention for one year. Patients enrolled should complete one-year follow-up in the form of clinic visit or telephone call.

Conditions

Percutaneous Coronary Intervention; Multivessel Coronary Artery Disease; Elderly Patients; C-Reactive Protein

Keywords

multivessel coronary artery disease; percutaneous coronary intervention; elderly patients; colchicine; high sensitive-C reactive protein; efficacy and safety

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

  Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke

  From randomization to occurence of first event, assessed up to one year

Secondary Outcomes (8)

• Cardiovascular death

  From randomization to occurence of first event, assessed up to one year

• Spontaneous (nonprocedural) myocardial infarction

  From randomization to occurence of first event, assessed up to one year

• Ischemia-driven coronary revascularization

  From randomization to occurence of first event, assessed up to one year

• Ischemic stroke

  From randomization to occurence of first event, assessed up to one year

• Change of hs-CRP

  From randomization to treatment at one month and one year

Other Outcomes (28)

• Nausea

  From randomization to treatment at one month and one year

• Vomiting

  From randomization to treatment at one month and one year

• Diarrhea

  From randomization to treatment at one month and one year

Study Arms (2)

Colchicine group

EXPERIMENTAL

Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.

Drug: colchicine

Control group

NO INTERVENTION

No intervention

Interventions

colchicine DRUG

Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.

Colchicine group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 60-80 years old
• Baseline plasma hs-CRP≥2 mg/L
• Hospitalized patients with coronary artery disease with multi-vessel lesions (multi-vessel lesions are defined as at least 2 major epicardial coronary arteries with ≥50% stenosis in their main branch diameter confirmed by coronary CT or coronary angiography, with or without left main artery disease)
• Patients with myocardial ischemia-related symptoms or objective evidence are successfully treated with PCI, and the condition is relatively stable
• Received standard drug therapies based on their condition at baseline (including antiplatelet, lipid-lowering, blood pressure control, blood glucose control, and other treatments recommended by guidelines)
• Subjects or legal representatives have signed informed consent.

You may not qualify if:

• Patients who have acute myocardial infarction within 30 days
• Patients who have taken colchicine and have a clear history of allergy or intolerance
• Patients with renal insufficiency, eGFR \<30 ml/min/1.73 m\^2 (calculated by MDRD formula) or blood creatinine levels exceeding 2 times the upper normal limit
• Patients with cirrhosis, chronic active hepatitis, liver function impairment (alanine aminotransferase exceeding 3 times the upper normal limit or total bilirubin exceeding 2 times the upper normal limit) or cholestasis
• Patients with a known history of hypomyelodysplasia
• Patients with heart failure (NYHA Class III-IV) or severe valvular disease
• Patients with concomitant neoplastic or cancer disease
• Patients with chronic obstructive pulmonary disease or other chronic pulmonary disease
• Patients with poorly controlled disease, such as current cardiogenic shock, hemodynamic instability, heart failure (NYHA Class III-IV), left ventricular ejection fraction less than 35%, recent stroke (within the past 3 months), or any other condition in which the investigator believes that participation in this study puts the patient at risk
• Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
• Patients with hemoglobin less than 115 g/L, white blood cell count less than 4.0\*10\^9/L, or platelet count less than 110\*10\^9/L
• Patients are currently using or plan to begin chronic systemic steroid therapy (oral or intravenous) during the study period (topical or inhaled steroids are allowed)
• Patients with acute inflammation or viral infection
• Female patients who are currently pregnant, planning to become pregnant, or breastfeeding

Sponsors & Collaborators

• Chinese Academy of Medical Sciences, Fuwai Hospital: lead

Study Sites (1)

Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Interventions

Colchicine

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Xueyan Zhao, M.D.

  Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xueyan Zhao, M.D.

CONTACT

86-10-88322051; zhao_xueyan@sina.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, M.D., FACC, FESC, Doctoral supervisor

Model Details: Open-label, Two-arm, Randomized, Superiority Trial

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: September 6, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: September 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)