AtherosclerosisPhase 1COPIXNCT05347316
Colchicine Effect on Perivascular Inflammation Index on Coronary CTA
A Phase 1 study testing Colchicine in people with Atherosclerosis and Inflammatory Response, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerosis, Inflammatory Response, Coronary Disease
- What is being tested?
- Colchicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Mar 2022to 7 Mar 2025
- Phase
- Phase 1
- 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
- Individuals of both sexes over 18 years of age;
- Patients undergoing coronary CT angiography from May/2021
- CT angiography showing non-calcified or mixed coronary plaques and high FAI value (> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with
- Willing and able (in the opinion of the investigators) to fulfill all study requirements
Who cannot join
- Past history of acute myocardial infarction
- History of percutaneous or surgical myocardial revascularization
- History of previous cardiac surgery or congenital heart disease
- Current use of colchicine
- Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy
- Active neoplasm with indication of surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasm and who underwent curative surgery without need for treatment in the last 12 months will be allowed)
Show all 14Show fewer
- Inflammatory bowel disease or chronic diarrhea
- Clinically significant non-transient hematologic abnormalities
- Renal dysfunction (GFR < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or < 220 µmol/l)
- Severe liver disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3x ULN in the last 6 months)
- Drug addiction or alcoholism
- History of clinically significant sensitivity to colchicine
- Inability to sign the informed consent form
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Heart Institute - University of São Paulo
São Paulo, São Paulo, 05403000
Carlos Serrano, Doctor, +55 11 2661 5352, cvserranojr@gmail.com
About this study
Official title: Colchicine Effect on Perivascular Inflammation Index on Coronary CTA(COPIX Trial)
Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.
Read the detailed description
A single-center, prospective, single-blind randomized study to evaluate the efficacy of colchicine versus placebo in patients with documented FAI ≥ -70.1 HU of the proximal segment of the right coronary artery and/ou left anterior descending coronary artery and non-calcified or mixed plaques on coronary angiography performed electively after 12-month follow-up.
- Conditions
- Atherosclerosis, Inflammatory Response, Coronary Disease
- Being tested
- Colchicine
- Keywords
- Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation
- Medical subject headings
- Atherosclerosis, Coronary Disease, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColchicineDrug
0.5 mg per day colchicine for 12 months
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | 0.5 mg of colchicine daily for 12 months Receives: Drug: Colchicine |
| Placebo | No intervention | Follow-up for 12 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of FAI in both groups after 12-month follow-up
Measured: 12 months
Secondary outcomes (7)
Evaluation of the variation total atheroma volume
Measured: 12 months
Evaluation of low attenuation plate volume variation;
Measured: 12 months
Occurrence of general death
Measured: 12 months
Occurrence of cardiovascular death
Measured: 12 months
Occurrence of acute myocardial infarction
Measured: 12 months
Occurrence of stroke
Measured: 12 months
Occurrence of need for myocardial revascularization
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 posted26 Apr 2022
- Study start7 Mar 2022
- Primary completion7 Mar 2023 (estimated)
- Study completion7 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Vicente Serrano Jr, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05347316
- Sponsor's protocol ID
- SDC 5327/21/102
- Acronym
- COPIX
- Status last verified
- May 2022
- First submitted
- 20 Apr 2022
- Last updated
- 9 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 9 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine Effect on Perivascular Inflammation Index on Coronary CTA(COPIX Trial)
- ClinicalTrials.gov ID
- NCT05347316
- Acronym / sponsor ID
- COPIX / SDC 5327/21/102
- Conditions
- Atherosclerosis, Inflammatory Response, Coronary Disease
- Keywords
- Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 7 Mar 2022 (actual)
- Primary completion
- 7 Mar 2023 (estimated)
- Study completion
- 7 Mar 2025 (estimated)
- First posted
- 26 Apr 2022 (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.
Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.
Detailed description
A single-center, prospective, single-blind randomized study to evaluate the efficacy of colchicine versus placebo in patients with documented FAI ≥ -70.1 HU of the proximal segment of the right coronary artery and/ou left anterior descending coronary artery and non-calcified or mixed plaques on coronary angiography performed electively after 12-month follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine0.5 mg of colchicine daily for 12 months |
| Placebo | No intervention | –Follow-up for 12 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals of both sexes over 18 years of age;
- Patients undergoing coronary CT angiography from May/2021
- CT angiography showing non-calcified or mixed coronary plaques and high FAI value (> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with
- Willing and able (in the opinion of the investigators) to fulfill all study requirements
Key exclusion criteria (14 listed)
- Past history of acute myocardial infarction
- History of percutaneous or surgical myocardial revascularization
- History of previous cardiac surgery or congenital heart disease
- Current use of colchicine
- Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy
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 |
|---|---|---|
| Colchicine0.5 mg per day colchicine for 12 months | Drug | Colchicine |
Primary outcome
Quantification of FAI in both groups after 12-month follow-up
Time frame: 12 months
7 secondary outcomes
Evaluation of the variation total atheroma volume
Time frame: 12 months
Evaluation of low attenuation plate volume variation;
Time frame: 12 months
Occurrence of general death
Time frame: 12 months
Occurrence of cardiovascular death
Time frame: 12 months
Occurrence of acute myocardial infarction
Time frame: 12 months
Occurrence of stroke
Time frame: 12 months
Occurrence of need for myocardial revascularization
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2022.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Colchicine in people with Atherosclerosis and Inflammatory Response, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 4 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 9 May 2022. 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 Brazil. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 CARLOS SERRANO, Doctor (+55(11) 26615447, cvserranojr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of FAI in both groups after 12-month follow-up (time frame: 12 months). 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 9 May 2022.