Your session is about to expire
← Back to Search
Anti-inflammatory
Colchicine for Cardiovascular Disease in Diabetes (CADENCE Trial)
Phase 3
Recruiting
Led By Kevin Boczar, MD
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients aged ≥18 years
Patients with Type 2 Diabetes (on diet, oral hypo-glycemic agents and/or insulin) or pre-diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
CADENCE Trial Summary
This trial will study whether the drug colchicine can help treat cardiovascular disease by reducing inflammation in patients who are at high risk for related events.
Who is the study for?
This trial is for adults over 18 with Type 2 Diabetes or pre-diabetes who've recently had a cardiovascular event like a heart attack or stroke. They must have stable symptoms and not be severely ill from other conditions. Pregnant women, those with severe liver, heart, or kidney issues, active infections, immune compromise, certain cancers within the last 3 years are excluded.Check my eligibility
What is being tested?
The study tests if Colchicine can reduce inflammation in blood vessel plaques in high-risk patients using FDG PET imaging. Participants will either receive Colchicine or a placebo to see if there's an effect on plaque inflammation which contributes to cardiovascular events.See study design
What are the potential side effects?
Colchicine may cause side effects such as digestive upset (like diarrhea), blood disorders (low counts of white cells and platelets), muscle pain/weakness, and possibly increased risk of infection due to its impact on the body's inflammatory response.
CADENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have Type 2 Diabetes or pre-diabetes and may be on medication or insulin.
CADENCE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
6 month change in FDG uptake TBR (Tissue to Blood Ratio) in the MDS (Maximum Disease Segment)
Secondary outcome measures
6 month change in FDG uptake SUV (standard uptake value) in the MDS of each vascular region: aorta, left and right carotid.
Aorta
Levels of Interleukin-6 (IL-6) (pg/ml) and its change.
+1 moreOther outcome measures
Exploratory outcomes - Levels of activated monocytes
Exploratory outcomes - MACE
Exploratory outcomes - Plasma levels of cytokines (pg/ml)
+4 moreCADENCE Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ColchicineExperimental Treatment1 Intervention
Colchicine: 0.6 mg colchicine capsule to be taken once a day.
Group II: PlaceboPlacebo Group1 Intervention
Placebo: Sugar pill manufactured to mimic colchicine 0.6 mg capsule. Placebo to be taken once a day.
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,321 Total Patients Enrolled
3 Trials studying Atherosclerosis
538 Patients Enrolled for Atherosclerosis
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,345 Previous Clinical Trials
26,453,652 Total Patients Enrolled
5 Trials studying Atherosclerosis
3,655 Patients Enrolled for Atherosclerosis
Kevin Boczar, MDPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
24 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need treatment for a serious heart valve problem.I am 18 years old or older.I have severe liver issues or my ALT levels are more than three times the normal limit.Your hemoglobin, white blood cell count, or platelet count is lower than a certain level.I haven't had cancer in the last 3 years, except for certain skin cancers or early-stage cervical cancer.I am not willing to use two forms of birth control during the study.I have chronic diarrhea.My heart failure is severe and not well-controlled.I have an active inflammatory condition or am on systemic anti-inflammatory therapy.I am allergic to dyes or my kidney function is low, so I will have a PET/CT instead of a CTA.I recently had a heart attack or stroke related to atherosclerosis.My kidney function is reduced with a GFR less than 50.I am currently taking strong medication that affects how drugs are processed in my body.My recent heart issue was likely due to a type of heart attack with clear arteries.My heart's pumping ability is severely reduced.I have atrial fibrillation and have had a stroke or TIA.I have Type 2 Diabetes or pre-diabetes and may be on medication or insulin.I am scheduled for a procedure to improve blood flow to the area affected by my heart attack or stroke, more than 120 days after the event.My health condition and blood pressure are stable.I currently have an active infection and am taking antibiotics.I often get infections due to a weak immune system.You recently had a serious heart or brain problem that was likely caused by a blood clot, according to your heart or brain doctor.I am unable to understand and give consent for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Colchicine
Awards:
This trial has 1 awards, including:- 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.
Atherosclerosis Patient Testimony for trial: Trial Name: NCT04181996 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical condition is Colchicine Oral Product most often prescribed for?
"Colchicine Oral Product is effective in treating gout flares and other disorders such as behcet's syndrome, postcommissurotomy syndrome, familial mediterranean fever."
Answered by AI
Is there still room for new participants in this clinical trial?
"Yes, the trial is ongoing and updated information can be found on clinicaltrials.gov. The study was first posted on 8/1/2020, with the most recent update being on 10/3/2022. They are looking for 115 patients from 1 location."
Answered by AI
What is the aim of this experiment?
"The primary outcome of this six-month clinical trial will be changes in FDG uptake TBR (Tissue to Blood Ratio) in the MDS (Maximum Disease Segment). Additionally, researchers will measure levels of Interleukin-6 (IL-6) (pg/ml), high-sensitivity C-Reactive Protein (hs-CRP) (mg/ml), andFDG uptake SUV (standard uptake value) in order to assess changes in each vascular region: aorta, left and right carotid."
Answered by AI
How many individuals are involved in this clinical trial?
"From what is published on clinicaltrials.gov, it appears that this study is still recruiting patients. The original posting date was 8/1/2020 and the most recent update was 10/3/2022. There is a goal to enroll 115 people total, at a single location."
Answered by AI
What are some other scientific studies that have used Colchicine Oral Product?
"There are 33 clinical trials currently studying Colchicine Oral Product with 13 of those in Phase 3. Some of these medical studies will soon be concluded as they have completed testing at their New york, New York locations. However, there are a total of 191 facilities running trials for Colchicine Oral Product across the globe."
Answered by AI
Has the Colchicine Oral Product gone through FDA approval?
"There is some efficacy data and multiple rounds of safety data, so Colchicine Oral Product receives a 3."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
What site did they apply to?
University of Ottawa Heart Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Wife, retired hospital pharmacist, found out about you online.
PatientReceived no prior treatments
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger