Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke (CONVINCE)
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|ClinicalTrials.gov Identifier: NCT02898610|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2016
Last Update Posted : March 1, 2023
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This study evaluates the use of Colchicine in adults over 40 years of age who have suffered an ischaemic stroke or transient ischaemic attack NOT caused by cardiac embolism or other defined causes. Patients will be randomised to 0.5 mg/day of Colchicine plus usual care, or to usual care alone.
To investigate the efficacy of low dose colchicine (0.5mg/day) plus usual care (defined as antiplatelet, lipid-lowering, antihypertensive treatment, and appropriate lifestyle advice) compared with usual care alone to prevent non-fatal recurrent ischaemic stroke, myocardial infarction, cardiac arrest, hospitalization for unstable angina and vascular death after ischaemic stroke or transient ischaemic attack (TIA) not caused by cardiac embolism or other defined causes unrelated to atherosclerosis
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Attack, Transient Stroke||Drug: Colchicine||Phase 3|
Inflammation is a key pathophysiological contributor to unstable atherosclerotic plaque and thrombo-embolic events, stroke, myocardial infarction, and vascular death. Internationally, clinical trials are targeting atherosclerotic inflammation in patients with coronary disease using methotrexate, colchicine, and canukinumab.
The primary aim is to compare low-dose colchicine (0.5mg/day) plus usual care, to usual care alone, to prevent non-fatal recurrent ischaemic stroke and coronary events and vascular death after non-severe, noncardioembolic TIA/stroke. Secondary objectives will investigate safety of low-dose colchicine, and efficacy for each component of the primary outcome, fatal and non-fatal events, disabling and non-disabling stroke, effect modification by prespecified subgroups, and impact on direct health care costs, adjusted for quality-adjusted life years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3154 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||CONVINCE - (COlchicine for preventioN of Vascular Inflammation in Non- CardioEmbolic Stroke) - a Randomised Clinical Trial of Low-dose Colchicine for Secondary Prevention After Stroke|
|Actual Study Start Date :||December 12, 2016|
|Actual Primary Completion Date :||November 21, 2022|
|Estimated Study Completion Date :||December 31, 2023|
Active Comparator: Colchicine treatment
Colchicine 0.5mg/day plus usual care for 60 months
No Intervention: Usual Standard of care alone
Normal standard of care remains for these patients
- Recurrence of non-fatal ischemic stroke [ Time Frame: any time within 60 month ]Any recurrence of non-fatal ischemic stroke
- on-fatal Major Cardiac event [ Time Frame: any time within 60 months ]Non-fatal hospitalization for unstable angina, myocardial infarction, cardiac arrest
- Vascular death [ Time Frame: 60 months ]Fatal ischemic stroke, myocardial infarction, cardiac arrest
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|Ages Eligible for Study:||40 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Written informed consent consistent with ICH-GCP guidelines and local laws signed prior to all trial-related procedures.
- Age 40 years or greater
- ischaemic stroke without major disability (modified Rankin score 3 or less)
- or high-risk TIA
- Qualifying stroke/TIA probably caused by large artery stenosis, small artery occlusion (lacunar stroke), or cryptogenic embolism, with cardiac embolism or other defined stroke mechanism deemed unlikely in the opinion of the treating physician.
- GFRgreater than or equal to 50 ml/min.
- In the opinion of the treating physician, patient is medically-stable, capable of participating in a randomised trial, and willing to attend follow-up.
- Cardio-embolic stroke/TIA, probably caused by identified atrial fibrillation (permanent or paroxysmal), in the opinion of the treating physician.
- Cardio-embolic stroke/TIA probably caused by other identified cardiac source (intra-cardiac thrombus, endocarditis, metallic heart valve, low ejection fraction <30%), in the opinion of the treating physician.
- Stroke/TIA caused by dissection, endocarditis, paradoxical embolism, drug use, venous thrombosis, within 48 hours aftercarotid or cardiac surgery, hypercoagulability states, migraine, or inherited cerebrovascular disorders (eg. Fabry's disease, CADASIL), in the opinion of the treating physician.
- History of myopathy or myalgias with raised creatine kinase (CK) on statin therapy.
- Blood dyscrasia defined as anaemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <150 x109/L) or leucopenia (white cell count <4 x109/L) at randomisation.
- Impaired hepatic function (transaminases greater than twice upper limit of normal) at randomisation.
- Concurrent treatment with moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram) or P-gp inhibitors (cyclosporine) at randomisation.
- Symptomatic peripheral neuropathy and pre-existing progressive neuromuscular disease
- Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhoea.
9. Dementia, sufficient to impair independence in basic activities of daily living.
10. Active malignancy, known hepatitis B or C, or HIV infection prior to qualifying stroke/TIA.
11. Impaired swallow preventing oral administration of study medication. 12. History of poor medication compliance. 13. Unlikely to comply with study procedures and follow-up visits due to severe or fatal comorbid illness or other factor (eg. inability to travel for follow up visits), in opinion of randomising physician.
14. Pregnancy, breast-feeding, or pre-menopausal women 15. Patient concurrently participating in another clinical trial with an investigational drug or device, or use of investigational drug within 30 days or 5 half-lives before the Screening visit (whichever is longer) 16. Known allergy or sensitivity to colchicine.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02898610
|Study Director:||Prof Peter Kelly||Mater Hospital|
|Responsible Party:||University College Dublin|
|Other Study ID Numbers:||
|First Posted:||September 13, 2016 Key Record Dates|
|Last Update Posted:||March 1, 2023|
|Last Verified:||February 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||A summary report of the trial will be provided to the Ethics Committees and relevant Regulatory Authority within as per national legal requirements in participating countries|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Ischemic Attack, Transient
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action