Coronary Artery DiseasePhase 4NCT06078904

Different Doses of Colchicine on hsCRP

A Phase 4 study testing Colchicine 0.5 MG, Colchicine 0.375 MG and Colchicine 0.25 MG in people with Coronary Artery Disease and Percutaneous Coronary Intervention, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease, Percutaneous Coronary Intervention
What is being tested?: Colchicine 0.5 MG, Colchicine 0.375 MG and Colchicine 0.25 MG
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 200 participants
Where: 1 siteChina
Study dates: 10 Oct 2023to 15 Apr 2024
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Volunteer to participate, understand and sign an informed consent form;
Age ≥ 18 years old, regardless of gender;
Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;
Complete all planned percutaneous coronary intervention during hospitalization;
Patient must be treated according to national guidelines for standard treatment of coronary heart disease.

Who cannot join

Known allergies to colchicine;
Colchicine was taken within 10 days before randomization;
Abnormal liver function test (alanine aminotransferase >3 times the upper limit of normal value);
Abnormal renal function test (eGFR<30mL/min);
Thrombocytopenia (platelet count <100 g/L);
Uncontrolled infectious diseases;

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Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, and malignant tumor, etc;
Pre-existing or plan for the administration of nonsteroidal anti-inflammatory drugs, hormones, immunomodulatory drugs, or chemotherapeutic drugs;
Pregnant women, lactating women or women of childbearing age who do not use effective contraceptives;
Any other circumstances in which the investigator judges that the patient is not suitable to participate in the clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022

Other trials in China

About this study

Official title: The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention

Colchicine reduced atherothrombotic cardiovascular events in the COLCOT and LoDoCo2 studies. US Food and Drug Administration approved colchicine as the first anti-inflammatory drug for cardiovascular diseases on June, 2023. However, there is a lack of evidence for colchicine in East Asian population with coronary heart disease, and its effectiveness and safety need further exploration. Therefore, this study aims to use different doses of colchicine to treat patients with coronary heart disease after percutaneous coronary intervention, explore the effects of different doses of colchicine on hsCRP levels, and find the optimal dose of colchicine for treating coronary heart disease in China.

Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention
Being tested: Colchicine 0.5 MG, Colchicine 0.375 MG, Colchicine 0.25 MG, Placebo
Medical subject headings: Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Colchicine 0.5 MGDrug
Colchicine 0.5 MG, one pill a day, oral intake
Colchicine 0.375 MGDrug
Colchicine 0.375 MG, one pill a day, oral intake
Colchicine 0.25 MGDrug
Colchicine 0.25 MG, one pill a day, oral intake
PlaceboDrug
Placebo, one pill a day, oral intake

Study groups in NCT06078904
Study group	Role	What they receive
Colchicine 0.5 MG	Active comparator	Colchicine 0.5 MG, one pill a day, oral intake Receives: Drug: Colchicine 0.5 MG
Colchicine 0.375 MG	Active comparator	Colchicine 0.375 MG, one pill a day, oral intake Receives: Drug: Colchicine 0.375 MG
Colchicine 0.25 MG	Active comparator	Colchicine 0.25 MG, one pill a day, oral intake Receives: Drug: Colchicine 0.25 MG
Placebo	Placebo comparator	Placebo, one pill a day, oral intake Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The percentage change in hsCRP
The percentage change in hsCRP compared to baseline
Measured: 4 weeks

Secondary outcomes (5)

Major adverse cardiac and cerebrovascular event (MACCE)
Composite endpoint of all cause death, non fatal myocardial infarction, non fatal stroke, and revascularization due to ischemia
Measured: 4 weeks
Bleeding
Bleeding defined according to Bleeding Academic Research Consortium
Measured: 4 weeks
Plasma inflammatory cytokines level
Inflammatory cytokines (IL-1β, IL-1receptor antagonist, IL-6, IL-18, tumor necrosis factor-α, myeloperoxidase, etc)
Measured: 4 weeks
Blood drug concentrations of different doses of colchicine
Blood drug concentrations of different doses of colchicine
Measured: 4 weeks
Expression of inflammation-related proteins in peripheral blood mononuclear cells
Inflammation-related proteins (nucleotide-binding oligomerization domain-like receptor protein 3, absent in melanoma 2, etc)
Measured: 4 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Oct 202315 Apr 2024

First posted12 Oct 2023
Study start10 Oct 2023
Primary completion25 Dec 2023
Study completion15 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe 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
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06078904
Sponsor's protocol ID: COLCRP
Status last verified: Apr 2024
First submitted: 5 Oct 2023
Last updated: 16 Apr 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.
PubMed 33769515
Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.
PubMed 37558377

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effects of Different Doses of Colchicine on High-sensitivity C-reactive Protein in Patients After Percutaneous Coronary Intervention
ClinicalTrials.gov ID: NCT06078904
Acronym / sponsor ID: COLCRP
Conditions: Coronary Artery Disease, Percutaneous Coronary Intervention
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Study start: 10 Oct 2023 (actual)
Primary completion: 25 Dec 2023 (actual)
Study completion: 15 Apr 2024 (actual)
First posted: 12 Oct 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Colchicine 0.5 MG	Active comparator	Drug: Colchicine 0.5 MGColchicine 0.5 MG, one pill a day, oral intake
Colchicine 0.375 MG	Active comparator	Drug: Colchicine 0.375 MGColchicine 0.375 MG, one pill a day, oral intake
Colchicine 0.25 MG	Active comparator	Drug: Colchicine 0.25 MGColchicine 0.25 MG, one pill a day, oral intake
Placebo	Placebo comparator	Drug: PlaceboPlacebo, one pill a day, oral intake

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Volunteer to participate, understand and sign an informed consent form;
Age ≥ 18 years old, regardless of gender;
Patient diagnosed with coronary heart disease requiring percutaneous coronary intervention;
Complete all planned percutaneous coronary intervention during hospitalization;
Patient must be treated according to national guidelines for standard treatment of coronary heart disease.

Key exclusion criteria (10 listed)

Known allergies to colchicine;
Colchicine was taken within 10 days before randomization;
Abnormal liver function test (alanine aminotransferase >3 times the upper limit of normal value);
Abnormal renal function test (eGFR<30mL/min);
Thrombocytopenia (platelet count <100 g/L);

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
Colchicine 0.5 MGColchicine 0.5 MG, one pill a day, oral intake	Drug	Colchicine 0.5 MG
Colchicine 0.375 MGColchicine 0.375 MG, one pill a day, oral intake	Drug	Colchicine 0.375 MG
Colchicine 0.25 MGColchicine 0.25 MG, one pill a day, oral intake	Drug	Colchicine 0.25 MG
PlaceboPlacebo, one pill a day, oral intake	Drug	Placebo

Primary outcome

The percentage change in hsCRP
Time frame: 4 weeks
The percentage change in hsCRP compared to baseline

5 secondary outcomes

Major adverse cardiac and cerebrovascular event (MACCE)
Time frame: 4 weeks
Bleeding
Time frame: 4 weeks
Plasma inflammatory cytokines level
Time frame: 4 weeks
Blood drug concentrations of different doses of colchicine
Time frame: 4 weeks
Expression of inflammation-related proteins in peripheral blood mononuclear cells
Time frame: 4 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
Background: PubMed 33769515Fiolet ATL, Opstal TSJ, Mosterd A, Eikelboom JW, Jolly SS, Keech AC, Kelly P, Tong DC, Layland J, Nidorf SM, Thompson PL, Budgeon C, Tijssen JGP, Cornel JH. Efficacy and safety of low-dose colchicine in patients with coronary disease: a systematic review and meta-analysis of randomized trials. Eur Heart J. 2021 Jul 21;42(28):2765-2775. doi: 10.1093/eurheartj/ehab115.
Background: PubMed 37558377Nelson K, Fuster V, Ridker PM. Low-Dose Colchicine for Secondary Prevention of Coronary Artery Disease: JACC Review Topic of the Week. J Am Coll Cardiol. 2023 Aug 15;82(7):648-660. doi: 10.1016/j.jacc.2023.05.055.
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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 10 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: finished, as of the sponsor's last update on 16 Apr 2024. 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The percentage change in hsCRP (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06078904, which also lists 2 linked publications.

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 16 Apr 2024.