Status:
UNKNOWN
COlchicine iN Circulating Inflammatory Markers After StrokE (CONCISE)
Lead Sponsor:
University College Dublin
Collaborating Sponsors:
Mater Misericordiae University Hospital
Conditions:
Ischemic Stroke
Atherosclerosis
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
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 athero...
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 wi...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT06062277
Start Date
October 1 2023
End Date
June 1 2025
Last Update
October 2 2023
Active Locations (1)
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1
Stroke Clinical Trials Network Ireland
Dublin, Ireland