Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE4

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-30

Study Completion Date

2025-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open-label, Two-arm, Randomized, Superiority Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.

Study Groups

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Colchicine group

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

Group Type EXPERIMENTAL

colchicine

Intervention Type DRUG

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

Control group

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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colchicine

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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

Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No