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Residual Inflammatory Risk-Guided colcHicine in Elderly Trial (RIGHT)

Primary Purpose

Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease, Elderly Patients

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
colchicine
Sponsored by
Chinese Academy of Medical Sciences, Fuwai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Percutaneous Coronary Intervention focused on measuring multivessel coronary artery disease, percutaneous coronary intervention, elderly patients, colchicine, high sensitive-C reactive protein, efficacy and safety

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Colchicine group

Control group

Arm Description

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

No intervention

Outcomes

Primary Outcome Measures

Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke

Secondary Outcome Measures

Cardiovascular death
Number of participants with cardiovascular death.
Spontaneous (nonprocedural) myocardial infarction
Number of participants with spontaneous (nonprocedural) myocardial infarction.
Ischemia-driven coronary revascularization
Number of participants with ischemia-driven coronary revascularization.
Ischemic stroke
Number of participants having had a ischemic stroke.
Change of hs-CRP
Change of hs-CRP comparing to the baseline
Change of white blood cell count
Change of white blood cell count comparing to the baseline
Change of neutrophil count
Change of neutrophil count comparing to the baseline
Change of monocyte count
Change of monocyte count comparing to the baseline

Full Information

First Posted
June 2, 2023
Last Updated
September 1, 2023
Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06025071
Brief Title
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
Acronym
RIGHT
Official Title
Efficacy and Safety of Residual Inflammatory Risk-Guided Low-dose Colchicine Therapy in Elderly Patients With Multivessel Coronary Artery Disease: A Multicenter Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences, Fuwai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Open-label, Two-arm, Randomized, Superiority Trial
Masking
Outcomes Assessor
Masking Description
This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Colchicine group
Arm Type
Experimental
Arm Description
Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
colchicine
Intervention Description
Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
Primary Outcome Measure Information:
Title
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Description
Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke
Time Frame
From randomization to occurence of first event, assessed up to one year
Secondary Outcome Measure Information:
Title
Cardiovascular death
Description
Number of participants with cardiovascular death.
Time Frame
From randomization to occurence of first event, assessed up to one year
Title
Spontaneous (nonprocedural) myocardial infarction
Description
Number of participants with spontaneous (nonprocedural) myocardial infarction.
Time Frame
From randomization to occurence of first event, assessed up to one year
Title
Ischemia-driven coronary revascularization
Description
Number of participants with ischemia-driven coronary revascularization.
Time Frame
From randomization to occurence of first event, assessed up to one year
Title
Ischemic stroke
Description
Number of participants having had a ischemic stroke.
Time Frame
From randomization to occurence of first event, assessed up to one year
Title
Change of hs-CRP
Description
Change of hs-CRP comparing to the baseline
Time Frame
From randomization to treatment at one month and one year
Title
Change of white blood cell count
Description
Change of white blood cell count comparing to the baseline
Time Frame
From randomization to treatment at one month and one year
Title
Change of neutrophil count
Description
Change of neutrophil count comparing to the baseline
Time Frame
From randomization to treatment at one month and one year
Title
Change of monocyte count
Description
Change of monocyte count comparing to the baseline
Time Frame
From randomization to the end of treatment at one year
Other Pre-specified Outcome Measures:
Title
Nausea
Description
Treatment-related adverse events as nausea
Time Frame
From randomization to treatment at one month and one year
Title
Vomiting
Description
Treatment-related adverse events as vomiting
Time Frame
From randomization to treatment at one month and one year
Title
Diarrhea
Description
Treatment-related adverse events as diarrhea
Time Frame
From randomization to treatment at one month and one year
Title
Abdominal pain
Description
Treatment-related adverse events as abdominal pain
Time Frame
From randomization to treatment at one month and one year
Title
Muscle pain
Description
Treatment-related adverse events as muscle pain
Time Frame
From randomization to treatment at one month and one year
Title
Neuritis
Description
Treatment-related adverse events as neuritis
Time Frame
From randomization to treatment at one month and one year
Title
Rash
Description
Treatment-related adverse events as rash
Time Frame
From randomization to treatment at one month and one year
Title
Gout
Description
Treatment-related adverse events as gout
Time Frame
From randomization to treatment at one month and one year
Title
Hospitalization for infections
Description
Treatment-related adverse events as hospitalization for infections
Time Frame
From randomization to treatment at one month and one year
Title
New tumors
Description
Treatment-related adverse events as new tumors
Time Frame
From randomization to treatment at one month and one year
Title
Blood pressure
Description
Both systolic and diastolic blood pressure
Time Frame
From randomization to treatment at one month and one year
Title
Heart rate
Time Frame
From randomization to treatment at one month and one year
Title
White blood cell count
Time Frame
From randomization to treatment at one month and one year
Title
Neutrophil count
Time Frame
From randomization to treatment at one month and one year
Title
Monocyte count
Time Frame
From randomization to treatment at one month and one year
Title
Hematocrit
Time Frame
From randomization to treatment at one month and one year
Title
Hemoglobin level
Time Frame
From randomization to treatment at one month and one year
Title
Platelet count
Time Frame
From randomization to treatment at one month and one year
Title
Alanine aminotransferase
Time Frame
From randomization to treatment at one month and one year
Title
Aspartate aminotransferase
Time Frame
From randomization to treatment at one month and one year
Title
Gamma-glutamyltransferase
Time Frame
From randomization to treatment at one month and one year
Title
Total bilirubin
Time Frame
From randomization to treatment at one month and one year
Title
Direct bilirubin
Time Frame
From randomization to treatment at one month and one year
Title
Serum albumin
Time Frame
From randomization to treatment at one month and one year
Title
Total serum protein
Time Frame
From randomization to treatment at one month and one year
Title
Serum creatinine
Time Frame
From randomization to treatment at one month and one year
Title
Blood urea nitrogen
Time Frame
From randomization to treatment at one month and one year
Title
Creatine Kinase
Time Frame
From randomization to treatment at one month and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xueyan Zhao, M.D.
Phone
86-10-88322051
Email
zhao_xueyan@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueyan Zhao, M.D.
Organizational Affiliation
Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xueyan Zhao, M.D.
Phone
86-10-88322051
Email
zhao_xueyan@sina.com
First Name & Middle Initial & Last Name & Degree
Xueyan Zhao, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No

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Residual Inflammatory Risk-Guided colcHicine in Elderly Trial

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