COlchicine iN Circulating Inflammatory Markers After StrokE (CONCISE)

NCT06062277 | Unknown Phase 2 DMC

• 1 other identifier: UCDCRC/23/04
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Ischemic Stroke; Atherosclerosis

Keywords

hsCRP; ischaemic stroke; atherosclerosis

Outcome Measures

Primary Outcomes (1)

• Change in hsCRP level

  Percentage change in hsCRP level

  4 weeks

Secondary Outcomes (3)

• Change in IL-6 level

  4 weeks

• Change in TNF-alpha level

  4 weeks

• Change in MCP-1 level

  4 weeks

Other Outcomes (1)

• Medication tolerability, adherence and acceptability

  4 weeks

Study Arms (1)

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.

Drug: Colchicine 0.5 MG

Interventions

Colchicine 0.5 MG DRUG

one oral tablet daily for 30 days

Single Arm Study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• University College Dublin: lead
• Mater Misericordiae University Hospital: collaborator

Study Sites (1)

Stroke Clinical Trials Network Ireland

Dublin, Ireland

Location

MeSH Terms

Conditions

Ischemic Stroke; Atherosclerosis

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Central Study Contacts

Sarah Gorey

CONTACT

+35318545243; sarah.gorey@ucd.ie

Katrina Tobin

CONTACT

+35317164576; isctni@ucd.ie

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Before and after intervention paired cohort study

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 2, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: June 1, 2025
• Last Updated: October 2, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)