Ischemic StrokePhase 2CONCISENCT06062277
COlchicine iN Circulating Inflammatory Markers After StrokE (CONCISE)
A Phase 2 study testing Colchicine 0.5 MG in people with Ischemic Stroke and Atherosclerosis, run by University College Dublin at 1 site in Ireland.
Trial summary
The goal of this phase 2, before-and-after interventional study is to investigate the effect of colchicine treatment on serum biomarkers of inflammation in patients with a history of stroke and atherosclerosis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Ischemic Stroke, Atherosclerosis
- What is being tested?
- Colchicine 0.5 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteIreland
- Study dates
- Oct 2023to Jun 2025
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Free of chronic kidney disease and eGFR>50ml/min on baseline blood tests
- Serum hsCRP≥2mg/L measured during the screening phase or on routine bloods in the year prior to recruitment.
- History of ischaemic stroke or TIA
- presence of atheroma, including intracranial or extracranial atheroma causing ≥30% stenosis or occlusion ipsilateral to the infarct; any atheroma proximal to the infarct in patients with cryptogenic stroke or ESUS in whom an alternative mechanism is not felt to be more likely in the opinion of the physician; history of ischaemic heart disease, peripheral arterial disease or has undergone revascularisation procedures for either.
Who cannot join
- Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal)
- Stroke or TIA caused by other identified cardiac source (intracardiac thrombus, endocarditis, metallic heart value, low ejection fraction <30%)
- History of myalgia with raised CK on statin therapy
- Blood dyscrasia (Hb <10g/dl; Plt <150x10^9/L; WCC <4x10^9/L) or other history of blood dyscrasia requiring follow-up with Haematology
- Impaired hepatic function (transaminases >twice ULN)
- Concurrent treatment with contra-indicated drugs: CYP3A4 inhibitors (e.g. clarithromycin, erythomycin, telithromycin, macrolides, ketoconazole, itraconazole, voriconazole, tolbutamide, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-GP inhibitors (e.g. cyclosporine) at screening
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- Symptomatic peripheral neuropathy or progressive neuromuscular disease
- Pre-existing inflammatory bowel disease, Crohn's disease, Ulcerative colitis or chronic diarrhoea
- Pre-existing inflammatory condition, intercurrent infection or other indication for regular anti-inflammatory therapies, e.g. steroid, NSAIDs, immunosuppressants.
- Requirement for colchicine therapy for acute gout or gout prevention or other rheumatological disorder.
- Known sensitivity of allergy to colchicine.
- Active malignancy or known Hepatitis B, C or HIV infection.
- Dementia or cognitive impairment sufficient to impair independence in basic activities of daily living.
- People of childbearing potential (Must be >24 months free of menstrual periods)
- Patient concurrently enrolled in the CONVINCE trial.
Trial locations and contacts
1 site in 1 country.
Ireland1 site
Stroke Clinical Trials Network Ireland
Dublin
Sarah Gorey, M.Sc, sarah.gorey@ucd.ie
Katrina Tobin, isctn@ucd.ie
About this study
Official title: Colchicine in Circulating Inflammatory Markers After Stroke
The goal of this phase 2, before-and-after interventional study is to investigate the effect of colchicine treatment on serum biomarkers of inflammation in patients with a history of stroke and atherosclerosis.
Participants meeting inclusion criteria will have blood samples drawn at baseline, will be dispensed colchicine 0.5mg daily for a treatment period of 30 days and have blood samples drawn again at follow-up. All blood samples will be analysed for a panel of inflammatory blood markers and the change in blood inflammatory markers from baseline to end of treatment will be calculated.
Read the detailed description
Patients with a history of stroke or TIA, atherosclerosis and hsCRP≥2mg/L at baseline will be eligible for inclusion. Participants ≥18 years and ≤90 years, with no race, ethnicity or sex exclusions will be recruited. The target sample size is 91 participants. The sample size was calculated based on a paired two-sided t-test, using a 33% effect size, setting alpha at 0.05 and power at 0.8, and allowing for up to 20% non-adherence with colchicine.
Participants will receive 30 days treatment with pleiotropic anti-inflammatory agent colchicine 0.5mg tablets orally once daily for 30 days. A panel of blood inflammatory markers will be drawn pre and post treatment. Outcomes will be the calculated change in blood inflammatory marker panel, including hsCRP and IL-6, comparing before treatment levels with after treatment levels. This is a before and after paired cohort study, each participant will act as their own control.
All participants will receive the intervention study medication, colchicine 0.5mg orally once daily. Medication adherence will be ascertained by pill count and tolerability assessed using the MAQ questionnaire. MAQ questionnaire is a 6 item questionnaire which will assess each participants perception of the convenience, taste, look and smell, effect, side-effects and overall acceptability of the study drug, colchicine, on a likert scale.
Baseline characteristics will be collected including participant demographics, past medical history, medication use, blood pressure, BMI. These assessments will be repeated at the follow-up visit. This information will be collected with participant consent via participant reported history, physical exam, office blood pressure and weight measurement, and with reference to medical notes.
- Conditions
- Ischemic Stroke, Atherosclerosis
- Being tested
- Colchicine 0.5 MG
- Keywords
- hsCRP, ischaemic stroke, atherosclerosis
- Medical subject headings
- Ischemic Stroke, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MGDrug
one oral tablet daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Other | Paired cohort before and after study. Each participant will act as their own control.
All participants will receive the intervention: study drug colchicine 0.5mg orally once daily for a treatment period of 30 days. Receives: Drug: Colchicine 0.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in hsCRP level
Percentage change in hsCRP level
Measured: 4 weeks
Secondary outcomes (3)
Change in IL-6 level
Percentage change in IL-6 level
Measured: 4 weeks
Change in TNF-alpha level
Percentage change in TNF-alpha level
Measured: 4 weeks
Change in MCP-1 level
Percentage change in MCP-1 level
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study startOct 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before and after intervention paired cohort study
- Masking
- None (open label)
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- Mater Misericordiae University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062277
- Sponsor's protocol ID
- UCDCRC/23/04
- Acronym
- CONCISE
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 2 Oct 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 2 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colchicine in Circulating Inflammatory Markers After Stroke
- ClinicalTrials.gov ID
- NCT06062277
- Acronym / sponsor ID
- CONCISE / UCDCRC/23/04
- Conditions
- Ischemic Stroke, Atherosclerosis
- Keywords
- hsCRP, ischaemic stroke, atherosclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- Mater Misericordiae University Hospital
- Study start
- Oct 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 2 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.
The goal of this phase 2, before-and-after interventional study is to investigate the effect of colchicine treatment on serum biomarkers of inflammation in patients with a history of stroke and atherosclerosis.
Participants meeting inclusion criteria will have blood samples drawn at baseline, will be dispensed colchicine 0.5mg daily for a treatment period of 30 days and have blood samples drawn again at follow-up. All blood samples will be analysed for a panel of inflammatory blood markers and the change in blood inflammatory markers from baseline to end of treatment will be calculated.
Detailed description
Patients with a history of stroke or TIA, atherosclerosis and hsCRP≥2mg/L at baseline will be eligible for inclusion. Participants ≥18 years and ≤90 years, with no race, ethnicity or sex exclusions will be recruited. The target sample size is 91 participants. The sample size was calculated based on a paired two-sided t-test, using a 33% effect size, setting alpha at 0.05 and power at 0.8, and allowing for up to 20% non-adherence with colchicine.
Participants will receive 30 days treatment with pleiotropic anti-inflammatory agent colchicine 0.5mg tablets orally once daily for 30 days. A panel of blood inflammatory markers will be drawn pre and post treatment. Outcomes will be the calculated change in blood inflammatory marker panel, including hsCRP and IL-6, comparing before treatment levels with after treatment levels. This is a before and after paired cohort study, each participant will act as their own control.
All participants will receive the intervention study medication, colchicine 0.5mg orally once daily. Medication adherence will be ascertained by pill count and tolerability assessed using the MAQ questionnaire. MAQ questionnaire is a 6 item questionnaire which will assess each participants perception of the convenience, taste, look and smell, effect, side-effects and overall acceptability of the study drug, colchicine, on a likert scale.
Baseline characteristics will be collected including participant demographics, past medical history, medication use, blood pressure, BMI. These assessments will be repeated at the follow-up visit. This information will be collected with participant consent via participant reported history, physical exam, office blood pressure and weight measurement, and with reference to medical notes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before and after intervention paired cohort study
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Other | Drug: Colchicine 0.5 MGPaired cohort before and after study. Each participant will act as their own control. All participants will receive the intervention: study drug colchicine 0.5mg orally once daily for a treatment period of 30 days. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Free of chronic kidney disease and eGFR>50ml/min on baseline blood tests
- Serum hsCRP≥2mg/L measured during the screening phase or on routine bloods in the year prior to recruitment.
- History of ischaemic stroke or TIA
- presence of atheroma, including intracranial or extracranial atheroma causing ≥30% stenosis or occlusion ipsilateral to the infarct; any atheroma proximal to the infarct in patients with cryptogenic stroke or ESUS in whom an alternative mechanism is not felt to be more likely in the opinion of the physician; history of ischaemic heart disease, peripheral arterial disease or has undergone revascularisation procedures for either.
Key exclusion criteria (15 listed)
- Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal)
- Stroke or TIA caused by other identified cardiac source (intracardiac thrombus, endocarditis, metallic heart value, low ejection fraction <30%)
- History of myalgia with raised CK on statin therapy
- Blood dyscrasia (Hb <10g/dl; Plt <150x10^9/L; WCC <4x10^9/L) or other history of blood dyscrasia requiring follow-up with Haematology
- Impaired hepatic function (transaminases >twice ULN)
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 MGone oral tablet daily for 30 days | Drug | Single Arm Study |
Primary outcome
Change in hsCRP level
Time frame: 4 weeks
Percentage change in hsCRP level
3 secondary outcomes
Change in IL-6 level
Time frame: 4 weeks
Change in TNF-alpha level
Time frame: 4 weeks
Change in MCP-1 level
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 0.5 MG in people with Ischemic Stroke and Atherosclerosis, run by University College Dublin at 1 site in Ireland.
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 15 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 2 Oct 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 Ireland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Sarah Gorey (+35318545243, sarah.gorey@ucd.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hsCRP level (time frame: 4 weeks). 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 2 Oct 2023.