Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke

• Register: ClinicalTrials.gov
• Last refreshed on: 13 March 2023
• Main ID: NCT02898610
• Date of registration: 08/09/2016
• Prospective Registration: Yes
• Primary sponsor: University College Dublin
• Public title: Colchicine for Prevention of Vascular Inflammation in Non-cardio Embolic Stroke CONVINCE
• Scientific 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
• Date of first enrolment: December 12, 2016
• Target sample size: 3154
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT02898610
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, Czechia, Denmark, Estonia, Germany, Ireland, Lithuania, Netherlands, Poland, Portugal, Spain, Switzerland, United Kingdom

Contacts

• Name: Prof Peter Kelly
• Affiliation: Mater Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Written informed consent consistent with ICH-GCP guidelines and local laws signed
prior to all trial-related procedures.

2. Age 40 years or greater

3. Either,

- ischaemic stroke without major disability (modified Rankin score 3 or less)

- or high-risk TIA

4. 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.

5. GFRgreater than or equal to 50 ml/min.

6. In the opinion of the treating physician, patient is medically-stable, capable of
participating in a randomised trial, and willing to attend follow-up.

Exclusion Criteria:

1. Cardio-embolic stroke/TIA, probably caused by identified atrial fibrillation
(permanent or paroxysmal), in the opinion of the treating physician.

2. 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.

3. 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.

4. History of myopathy or myalgias with raised creatine kinase (CK) on statin therapy.

5. Blood dyscrasia defined as anaemia (haemoglobin <10g/dL), thrombocytopenia (platelet
count <150 x109/L) or leucopenia (white cell count <4 x109/L) at randomisation.

6. Impaired hepatic function (transaminases greater than twice upper limit of normal) at
randomisation.

7. 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.

8. Symptomatic peripheral neuropathy and pre-existing progressive neuromuscular disease

9. 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Ischemic Attack, Transient

Intervention(s)

Drug: Colchicine

Primary Outcome(s)

on-fatal Major Cardiac event [Time Frame: any time within 60 months]

Recurrence of non-fatal ischemic stroke [Time Frame: any time within 60 month]

Vascular death [Time Frame: 60 months]

Secondary ID(s)

2015-004505-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Edinburgh

Universitaire Ziekenhuizen KU Leuven

Health Research Board, Ireland

Irish Heart Foundation

University of Athens

National University of Ireland, Galway, Ireland

Universitat de Lleida

University of Limerick