Acute Coronary SyndromePhase 4COLOCTNCT04848857
Colchicine for the Stability of Coronary Plaque in Acute Coronary Syndrome (COLOCT)
A Phase 4 study testing Colchicine in people with Acute Coronary Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.
Trial summary
Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Colchicine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 3 May 2021to 5 Oct 2023
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who understand and sign the informed consent form voluntarily.
- Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
- hospitalized patients diagnosed with acute coronary syndrome within 1 month.
- at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% by visual estimation on coronary angiography (CAG) after completing any planned percutaneous revascularization.
- the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).
Who cannot join
- Allergic to colchicine.
- Colchicine was taken within 10 days before randomization.
- Abnormal liver function (ALT > 3 times the upper limit of normal value).
- Abnormal renal function (creatinine clearance rate < 45 ml/min).
- Thrombocytopenia (PLT < 100G/L).
- Uncontrolled infectious diseases during the screening period.
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- Known immune diseases or immune-related diseases such as systemic lupus erythematosus, asthma, inflammatory bowel disease, gout, malignant tumor and so on.
- Pre-existing or plan for the administration of systemic anti-inflammatory treatments such as non-steroidal anti-inflammatory drugs, hormones, immunomodulatory and chemotherapeutic drugs.
- History of surgery or interventional therapy within 6 months prior to the screening period.
- A history of coronary artery bypass grafting or a plan for coronary artery bypass grafting within 1 year.
- Left main coronary disease (≥50% reduction in lumen diameter by angiographic visual estimation).
- Significant coronary calcification or tortuosity deemed to preclude OCT evaluation.
- Diagnosed with mental disorders such as anxiety or depression.
- Pregnant women, lactating women or women of childbearing age who do not use effective contraceptive methods.
- Participated in other clinical trials within 3 months before the screening period.
- Do not receive standardized treatment after being diagnosed with coronary heart disease.
- The life expectancy of the subjects is less than 1 year.
- The researchers determined that other conditions in which the patient was not suitable to participate in the clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy and Safety of Colchicine in Improving the Stability of Coronary Plaque in Patients With Acute Coronary Syndrome
Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine. Optical coherence tomography (OCT) is the most precise method to detect plaque stability in clinical practice. Thus, the purpose of this study is to evaluate the efficacy and safety of colchicine on improving the stability of coronary plaque in patients with acute coronary syndrome.
Read the detailed description
This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert readers.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Colchicine, Placebo
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
colchicine is a potent anti-inflammatory drug which is currently recommended for the treatment of pericarditis and acute gout attacks, but also familial Mediterranean fever and Behçet disease. This drug acts on inflammation through inhibition of microtubule polymerization by binding free tubule dimers. Colchicine blunts monocyte and neutrophil invasion at the site of inflammation and reduces intracellular trafficking and thus the release of cytokine and production of reactive oxygen species and a variety of proteolytic enzymes.
PlaceboDrug
the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | colchicine (0.5mg), one pill a day, oral intake Receives: Drug: Colchicine |
| Control Group | 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.
changes of the Thickness of fibrous cap of coronary artery plaque
changes of the thickness of fibrous cap of coronary artery plaque measured by OCT
Measured: 12 months
Secondary outcomes (6)
changes of the Average lipid arc of coronary artery plaque
changes of the average lipid arc of coronary artery plaque measured by OCT
Measured: 12 months
changes of the Macrophage accumulation in coronary artery plaque
changes of the macrophage accumulation in coronary artery plaque measured by OCT
Measured: 12 months
changes of the Incidence of thin-cap fibroatheroma (TCFA)
changes of the incidence of TCFA measured by OCT
Measured: 12 months
changes of the Minimum lumen area (MLA)
changes of the MLA measured by OCT
Measured: 12 months
changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO)
changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO)
Measured: 12 months
major adverse cardiovascular and cerebrovascular events (MACCEs)
A composite of all-cause death, nonfatal myocardial infarction, nonfatal stroke, revascularization due to ischemia
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start3 May 2021
- Primary completion20 Aug 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiang Cheng, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04848857
- Sponsor's protocol ID
- CTACS202001
- Acronym
- COLOCT
- Status last verified
- Dec 2023
- First submitted
- 14 Apr 2021
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu M, Yang Y, Dong SL, Zhao C, Yang F, Yuan YF, Liao YH, He SL, Liu K, Wei F, Jia HB, Yu B, Cheng X. Effect of Colchicine on Coronary Plaque Stability in Acute Coronary Syndrome as Assessed by Optical Coherence Tomography: The COLOCT Randomized Clinical Trial. Circulation. 2024 Sep 24;150(13):981-993. doi: 10.1161/CIRCULATIONAHA.124.069808. Epub 2024 Aug 21.
PubMed 39166327
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Colchicine in Improving the Stability of Coronary Plaque in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT04848857
- Acronym / sponsor ID
- COLOCT / CTACS202001
- Conditions
- Acute Coronary Syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 3 May 2021 (actual)
- Primary completion
- 20 Aug 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 19 Apr 2021 (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.
Evidence from the COLCOT Trial has shown that anti-inflammatory effect of colchicine reduced the risk of cardiovascular events in patients with recent myocardial infarction. We hypothesized that this might be due to the improvement of the coronary plaque stability by colchicine. Optical coherence tomography (OCT) is the most precise method to detect plaque stability in clinical practice. Thus, the purpose of this study is to evaluate the efficacy and safety of colchicine on improving the stability of coronary plaque in patients with acute coronary syndrome.
Detailed description
This is a single-center, randomized, double-blind, placebo-controlled clinical trial. OCT coronary images analyzed at an independent imaging core laboratory (Department of Cardiology, Second Affiliated Hospital of Harbin Medical University, Harbin, China) by blinded expert readers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Drug: Colchicinecolchicine (0.5mg), one pill a day, oral intake |
| Control Group | Placebo comparator | Drug: Placeboplacebo, one pill a day, oral intake |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who understand and sign the informed consent form voluntarily.
- Age ≥ 18 years old and ≤ 80 years old, regardless of sex.
- hospitalized patients diagnosed with acute coronary syndrome within 1 month.
- at least one non-culprit lesion with diameter stenosis percentage of 30% to 70% by visual estimation on coronary angiography (CAG) after completing any planned percutaneous revascularization.
- the lesion shown by OCT was lipid-rich plaque (Lipid pool arc > 90 °).
Key exclusion criteria (18 listed)
- Allergic to colchicine.
- Colchicine was taken within 10 days before randomization.
- Abnormal liver function (ALT > 3 times the upper limit of normal value).
- Abnormal renal function (creatinine clearance rate < 45 ml/min).
- Thrombocytopenia (PLT < 100G/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 |
|---|---|---|
| Colchicinecolchicine is a potent anti-inflammatory drug which is currently recommended for the treatment of pericarditis and acute gout attacks, but also familial Mediterranean fever and Behçet disease. This drug acts on inflammation through inhibition of microtubule polymerization by binding free tubule dimers. Colchicine blunts monocyte and neutrophil invasion at the site of inflammation and reduces intracellular trafficking and thus the release of cytokine and production of reactive oxygen species and a variety of proteolytic enzymes. | Drug | Treatment Group |
| Placebothe placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine. | Drug | Control Group |
Primary outcome
changes of the Thickness of fibrous cap of coronary artery plaque
Time frame: 12 months
changes of the thickness of fibrous cap of coronary artery plaque measured by OCT
6 secondary outcomes
changes of the Average lipid arc of coronary artery plaque
Time frame: 12 months
changes of the Macrophage accumulation in coronary artery plaque
Time frame: 12 months
changes of the Incidence of thin-cap fibroatheroma (TCFA)
Time frame: 12 months
changes of the Minimum lumen area (MLA)
Time frame: 12 months
changes of the inflammatory biomarkers (hsCRP, IL-6, and MPO)
Time frame: 12 months
major adverse cardiovascular and cerebrovascular events (MACCEs)
Time frame: 12 months
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 19 Dec 2023.
- Derived from this study: PubMed 39166327Yu M, Yang Y, Dong SL, Zhao C, Yang F, Yuan YF, Liao YH, He SL, Liu K, Wei F, Jia HB, Yu B, Cheng X. Effect of Colchicine on Coronary Plaque Stability in Acute Coronary Syndrome as Assessed by Optical Coherence Tomography: The COLOCT Randomized Clinical Trial. Circulation. 2024 Sep 24;150(13):981-993. doi: 10.1161/CIRCULATIONAHA.124.069808. Epub 2024 Aug 21.
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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?
A Phase 4 study testing Colchicine in people with Acute Coronary Syndrome, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 5 inclusion and 18 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 19 Dec 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. 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?
changes of the Thickness of fibrous cap of coronary artery plaque (time frame: 12 months). 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 NCT04848857, which also lists 1 linked publication.
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 19 Dec 2023.