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Anti-inflammatory agent
Colchicine for Stroke Prevention (CONVINCE Trial)
Phase 3
Waitlist Available
Research Sponsored by University College Dublin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months
Awards & highlights
CONVINCE Trial Summary
This trial will study if colchicine can prevent stroke in those over 40 who have already had one.
Who is the study for?
Adults over 40 who've had a stroke or TIA not due to cardiac embolism can join. They must be stable, able to participate in follow-ups, and have a GFR of at least 50 ml/min. Excluded are those on certain drugs, with severe illnesses, pregnant women, or with conditions like dementia that affect daily living.Check my eligibility
What is being tested?
The trial tests if Colchicine (0.5 mg/day) plus usual care is better than usual care alone for preventing further strokes or heart issues after an ischemic stroke/TIA not caused by cardiac embolism.See study design
What are the potential side effects?
Colchicine may cause digestive problems like diarrhea, nausea; blood disorders; muscle pain or weakness; and could potentially lead to serious allergic reactions in those sensitive to the drug.
CONVINCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recurrence of non-fatal ischemic stroke
Vascular death
on-fatal Major Cardiac event
CONVINCE Trial Design
2Treatment groups
Active Control
Group I: Colchicine treatmentActive Control1 Intervention
Colchicine 0.5mg/day plus usual care for 60 months
Group II: Usual Standard of care aloneActive Control1 Intervention
Normal standard of care remains for these patients
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Who is running the clinical trial?
Universitaire Ziekenhuizen LeuvenOTHER
849 Previous Clinical Trials
1,236,216 Total Patients Enrolled
17 Trials studying Stroke
2,297 Patients Enrolled for Stroke
University College DublinLead Sponsor
142 Previous Clinical Trials
106,144 Total Patients Enrolled
3 Trials studying Stroke
222 Patients Enrolled for Stroke
Health Research Board, IrelandOTHER
40 Previous Clinical Trials
12,954 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently taking certain medications that can interact with the study drug.You have dementia that makes it hard for you to do everyday tasks on your own.You are 40 years old or older.You had a stroke or mini-stroke likely caused by a specific kind of irregular heartbeat.You had a stroke or mini-stroke caused by a heart problem like a blood clot, infection in the heart, or a heart valve issue, according to your doctor's opinion.You have had a minor stroke or a high-risk mini-stroke.You have a current cancer, hepatitis B or C, or HIV infection before the stroke or mini-stroke.You have difficulty swallowing and can't take the study medication by mouth.You have a history of muscle pain or weakness with high levels of a protein called creatine kinase while taking statin medication.You had a stroke or mini-stroke likely caused by certain artery blockages or a specific type of embolism, and it's unlikely that another type of stroke caused it.Your liver function tests show that your liver is not working properly.You have nerve problems that cause symptoms, or a progressive muscle or nerve disease.You have Crohn's disease, ulcerative colitis, or chronic diarrhea.You have a history of not taking your medications as prescribed.You are allergic to colchicine.You had a stroke or mini-stroke caused by certain conditions or within 48 hours after certain surgeries, as determined by your doctor.You have low levels of red blood cells, platelets, or white blood cells in your blood.Your kidney function is good, with a GFR of 50 ml/min or more.
Research Study Groups:
This trial has the following groups:- Group 1: Colchicine treatment
- Group 2: Usual Standard of care alone
Awards:
This trial has 4 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA approved Colchicine as a viable therapeutic option?
"Data has demonstrated that Colchicine is a safe treatment option, so it got a rating of 3."
Answered by AI
What medical ailments can be remedied with Colchicine?
"Colchicine is a helpful treatment for gout flares, as well as behcet's syndrome, postcommissurotomy syndrome, and familial mediterranean fever."
Answered by AI
Have experiments with Colchicine been conducted prior to this one?
"Presently, 30 research projects are exploring the use of Colchicine in patients with 13 trials at Phase 3. Out of the 354 clinical trial sites operating studies on this medication, several are based in New york City."
Answered by AI
What is the geographic scope of this experiment's implementation?
"A total of 159 clinical trial sites are available for enrollment, with AZ St. Lucas, BRUGGE in Brugge, UCL Brussels in Brussel and UZ Brussel in Gent being some of the most prominent ones."
Answered by AI
How many individuals are being considered for inclusion in this trial?
"Unfortunately, this trial is not taking on additional participants. It was initially published in December 2016 and last revised on February 27th 2023. However, there are currently 1363 trials looking for stroke patients as well as 30 studies actively recruiting individuals who require Colchicine treatment."
Answered by AI
Is this medical trial accepting new participants at the present moment?
"Clinicaltrials.gov indicates that this trial is no longer actively enrolling patients, having originally been posted on December 12th 2016 and last updated February 27th 2023. However, 1393 other clinical trials are presently recruiting participants as of now."
Answered by AI
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