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CONCISE COlchicine iN Circulating Inflammatory markers after StrokE
EU CTIS ID: 2023-506967-33-00
What this study is testing
Vascular inflammation drives risk of recurrent stroke, cardiac and vascular events in patients with atheroma and atherosclerosis. Anti inflammatory therapies, such as colchicine, can reduce the risk of further events but little is known whether colchicine also lowers serum biomarkers of inflammation. Patients with a history of stroke or TIA and evidence of atherosclerosis at any site, defined as any of: intra-cranial or extra-cranial atheroma causing >30% stenosis or occlusion ipsilateral to the infarct Any atheroma proximal to the infarct in patients with cryptogenic stroke/ESUS in whom an alternative mechanism if not felt to be more likely in the opinion of the investigator Patient has a history of ischemic heart disease (IHD) or peripheral vascular disease (PVD), or has undergone revascularisation procedures for IHD or PVD. and raised hsCRP ³2mg/L on baseline blood tests will be eligible for inclusion. Patients will be prescribed pleotropicanti-inflammatory colchicine 0.5mg daily for 30 days. A panel of blood biomarkers will be drawn pre and post treatment. The primary outcome will be calculated % change in hsCRP , IL-6 and other blood biomarkers of inflammation comparing before treatment with after treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Prior ischaemic stroke or ischaemic attack.
- Living at home and independent (walking without the aid of another person, but may have some help for daily activities) without cognitive impairment causing limitation of daily function.
- Medically-stable, and capable of participating in a research study and likely to follow study procedures, in the opinion of the study physician
- Willing to provide informed consent
- Age >18 years and <90 years
- No history of chronic kidney disease and eGFR>50ml/min measured during screening phase
You likely can't join if
- Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal)
- Requirement for colchicine therapy for acute gout or gout prevention or other rheumatological disorder.
- Known sensitivity or 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.
- Women of childbearing potential. (Must be >24 months free of menstrual periods)
See the full eligibility criteria
- Prior ischaemic stroke or ischaemic attack.
- Living at home and independent (walking without the aid of another person, but may have some help for daily activities) without cognitive impairment causing limitation of daily function.
- Medically-stable, and capable of participating in a research study and likely to follow study procedures, in the opinion of the study physician
- Willing to provide informed consent
- Age >18 years and <90 years
- No history of chronic kidney disease and eGFR>50ml/min measured during screening phase
- Serum hsCRP³2mg/L measured within 6 months of study entry
- History of ischaemic stroke or TIA defined as a. Cerebral, spinal cord or retinal ischaemia based on neuropathological or neuroimaging evidence or clinical evidence of permanent injury. TIA= neurological dysfunction caused by focal cerebral or retinal ischaemia with clinical symptoms lasting <24 hours.
- Presence of atheroma defined as: - intra-cranial or extra-cranial atheroma causing >30% stenosis or occlusion ipsilateral to the infarct AND/OR - Any atheroma proximal to the infarct in patients with cryptogenic stroke/ESUS in whom an alternative mechanism if not felt to be more likely in the opinion of the investigator AND/OR - Patient has a history of ischemic heart disease (IHD) or peripheral arterial disease (PAD), or has undergone revascularisation procedures for IHD or PAD.
- Stroke or TIA likely caused by identified atrial fibrillation (permanent or paroxysmal)
- Requirement for colchicine therapy for acute gout or gout prevention or other rheumatological disorder.
- Known sensitivity or 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.
- Women of childbearing potential. (Must be >24 months free of menstrual periods)
- Patient concurrently enrolled in CONVINCE trial.
- 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 <150x1o^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 (clarithromycin, erythromycin, telithromycin, macrolides, ketoconazole, itraconazole, voriconazole, tolbutamide, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-gp inhibitors (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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.