Percutaneous Coronary InterventionPhase 4RIGHTNCT06025071
Residual Inflammatory Risk-Guided colcHicine in Elderly Trial
A Phase 4 study testing colchicine in people with Percutaneous Coronary Intervention and Multivessel Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Percutaneous Coronary Intervention, Multivessel Coronary Artery Disease, Elderly Patients
- What is being tested?
- colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- Sep 2023to Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
Beijing, Beijing Municipality, 100037
Xueyan Zhao, M.D., 86-10-88322051, zhao_xueyan@sina.com
Xueyan Zhao, M.D.
About this study
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
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
- Being tested
- colchicine
- Keywords
- multivessel coronary artery disease, percutaneous coronary intervention, elderly patients, colchicine, high sensitive-C reactive protein, efficacy and safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colchicineDrug
Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
| Study group | Role | What they receive |
|---|---|---|
| Colchicine group | Experimental | Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed. Receives: Drug: colchicine |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke
Measured: From randomization to occurence of first event, assessed up to one year
Secondary outcomes (8)
Cardiovascular death
Number of participants with cardiovascular death.
Measured: From randomization to occurence of first event, assessed up to one year
Spontaneous (nonprocedural) myocardial infarction
Number of participants with spontaneous (nonprocedural) myocardial infarction.
Measured: From randomization to occurence of first event, assessed up to one year
Ischemia-driven coronary revascularization
Number of participants with ischemia-driven coronary revascularization.
Measured: From randomization to occurence of first event, assessed up to one year
Ischemic stroke
Number of participants having had a ischemic stroke.
Measured: From randomization to occurence of first event, assessed up to one year
Change of hs-CRP
Change of hs-CRP comparing to the baseline
Measured: From randomization to treatment at one month and one year
Change of white blood cell count
Change of white blood cell count comparing to the baseline
Measured: From randomization to treatment at one month and one year
Change of neutrophil count
Change of neutrophil count comparing to the baseline
Measured: From randomization to treatment at one month and one year
Change of monocyte count
Change of monocyte count comparing to the baseline
Measured: From randomization to the end of treatment at one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionOct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open-label, Two-arm, Randomized, Superiority Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueyan Zhao, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Xueyan Zhao, M.D., Principal investigator, Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025071
- Sponsor's protocol ID
- 2023-GSP-GG-40
- Acronym
- RIGHT
- Status last verified
- Sep 2023
- First submitted
- 2 Jun 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06025071
- Acronym / sponsor ID
- RIGHT / 2023-GSP-GG-40
- 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
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Open-label, Two-arm, Randomized, Superiority Trial
| Arm | Type | Receives |
|---|---|---|
| Colchicine group | Experimental | Drug: colchicineDrug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed. |
| Control group | No intervention | –No intervention |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colchicineDosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed. | Drug | Colchicine group |
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: From randomization to occurence of first event, assessed up to one year
Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke
8 secondary outcomes
Cardiovascular death
Time frame: From randomization to occurence of first event, assessed up to one year
Spontaneous (nonprocedural) myocardial infarction
Time frame: From randomization to occurence of first event, assessed up to one year
Ischemia-driven coronary revascularization
Time frame: From randomization to occurence of first event, assessed up to one year
Ischemic stroke
Time frame: From randomization to occurence of first event, assessed up to one year
Change of hs-CRP
Time frame: From randomization to treatment at one month and one year
Change of white blood cell count
Time frame: From randomization to treatment at one month and one year
Change of neutrophil count
Time frame: From randomization to treatment at one month and one year
Change of monocyte count
Time frame: From randomization to the end of treatment at one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueyan Zhao, M.D. principal investigator
Fuwai Hospital, National Center for Cardiovascular Diseases, CAMS & PUMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing colchicine in people with Percutaneous Coronary Intervention and Multivessel Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xueyan Zhao, M.D. (86-10-88322051, zhao_xueyan@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (time frame: From randomization to occurence of first event, assessed up to one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.