COlchicine iN Circulating Inflammatory Markers After StrokE (CONCISE)

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University College Dublin
• Collaborator: Mater Misericordiae University Hospital
• Treatments: Colchicine

Criteria

Inclusion Criteria:

1. Free of chronic kidney disease and eGFR>50ml/min on baseline blood tests

2. Serum hsCRP≥2mg/L measured during the screening phase or on routine bloods in the year prior to recruitment.

3. History of ischaemic stroke or TIA

4. 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 Criteria:

1. Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal)

2. Stroke or TIA caused by other identified cardiac source (intracardiac thrombus, endocarditis, metallic heart value, low ejection fraction <30%)

3. History of myalgia with raised CK on statin therapy

4. Blood dyscrasia (Hb <10g/dl; Plt <150x10^9/L; WCC <4x10^9/L) or other history of blood dyscrasia requiring follow-up with Haematology

5. Impaired hepatic function (transaminases >twice ULN)

6. 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

7. Symptomatic peripheral neuropathy or progressive neuromuscular disease

8. Pre-existing inflammatory bowel disease, Crohn's disease, Ulcerative colitis or chronic diarrhoea

9. Pre-existing inflammatory condition, intercurrent infection or other indication for regular anti-inflammatory therapies, e.g. steroid, NSAIDs, immunosuppressants.

10. Requirement for colchicine therapy for acute gout or gout prevention or other rheumatological disorder.

11. Known sensitivity of allergy to colchicine.

12. Active malignancy or known Hepatitis B, C or HIV infection.

13. Dementia or cognitive impairment sufficient to impair independence in basic activities of daily living.

14. People of childbearing potential (Must be >24 months free of menstrual periods)

15. Patient concurrently enrolled in the CONVINCE trial.