CONVINCE (COlchicine for preventioN of Vascular Inflammation in Non-CardioEmbolic stroke) - a randomised clinical trial of low-dose colchicine for secondary prevention after stroke.
- Conditions
- 10007963Cerbrovascular Events. Stroke.
- Registration Number
- NL-OMON49701
- Lead Sponsor
- niversity College Dublin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
1 Written informed consent consistent with ICH-GCP guidelines and local laws
signed prior to all
trial-related procedures. 2 Age 40 years or greater3 A brain CT or MRI
has excluded primary intracranial haemorrhage4a. Patient diagnosed with -
An ischaemic stroke without major disability (modified Rankin score 3
or less)
Or
4b. A high-risk - defined as (one or more of the following)
TIA with DWI hyperintensity on acute MRI
TIA with ABCD2 >= 4
TIA with >= 50% Stenosis of the artery territory consistent with symptoms. 5
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.6 The
stroke/TIA has occurred more than 72 hours before randomisation AND no more
than 28
days prior to randomisation.7 eGFR greater than or equal to 50
ml/min.8. In the opinion of the treating physician, patient is
medically-stable, capable of participating in a
randomised trial, and willing to attend follow-up.
1. Stroke/TIA, probably caused by identified atrial fibrillation (permanent or
paroxysmal), in the
opinion of the treating physician.2. Stroke/TIA probably caused by other
identified cardiac source (intra-cardiac thrombus,
endocarditis, metallic heart valve, low ejection fraction <30%), 3.
Stroke/TIA caused by dissection, endocarditis, paradoxical embolism, drug use,
venous
thrombosis, carotid or cardiac surgery, hypercoagulability states,
migraine, or inherited
cerebrovascular disorders .4. History of myopathy or myalgias with raised
creatine kinase (CK) on statin therapy.5. Blood dyscrasia (haemoglobin
<10g/dLplatelet count <150 x109/L,white cell count <4 x109/L) 6. Impaired
hepatic function (transaminsases ALT and/or AST greater than twice upper limit
of
normal) 7. Concurrent treatment with colchicine contraindicated drugs:-
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
disease9. Inflammatory bowel disease (Crohn*s or ulcerative colitis) or chronic
diarrhoea.10. Dementia, sufficient to impair independence in basic activities
of daily living.11. Active malignancy, known hepatitis B or C, or HIV
infection.12. Impaired swallow preventing oral administration of Colchicine13.
History of poor medication compliance.14. Unlikely to comply with study
procedures due to severe or fatal comorbid illness or other factor
(eg. inability to travel for follow up visits), in opinion of randomising
physician.15. Pregnancy, breast-feeding, or pre-menopausal woman 16. Patient
concurrently participating in another clinical trial with an investigational
drug or device, or
use of investigational drug within 30 days of the Screening visit or 5
half lives before the
screening visit (whichever is longer) 17. Known allergy or sensitivity to
colchicine.18. Requirement for colchicine therapy for treatment of acute gout,
gout prevention, or other rheumatological disorder19. Requirement for chronic
daily immunosuppressants,
oral steroids, or non-steroidal anti-inflammatory drugs (NSAIDs)
-term stroke/TIA survivors. In a systema
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method