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Colchicine + Aspirin for Cardiovascular Disease in Type 2 Diabetes (COLCOT-T2D Trial)
COLCOT-T2D Trial Summary
This trial looks at if colchicine & non-enteric coated aspirin help reduce cardiovascular risks for those with type 2 diabetes.
COLCOT-T2D Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowCOLCOT-T2D Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.COLCOT-T2D Trial Design
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Who is running the clinical trial?
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- My muscle enzyme levels are more than three times the normal limit and have been confirmed by repeat tests.My kidney function is low, with an eGFR below 35 mL/min/1.73m2.I am on long-term medication for inflammation, such as anti-TNF or NSAIDs.I have low blood counts or liver issues as confirmed by recent tests.I have had a stroke or surgery due to severe narrowing of my brain's blood vessels.I have complications from diabetes affecting my eyes or nerves.I have had diabetes for 5 years or more.I haven't had cancer, except for certain skin cancers or early-stage cervical or prostate cancer, in the last 3 years.I am between 55 and 80 years old.I have never had a heart-related event due to blocked arteries.I cannot have children due to surgery or being postmenopausal.I understand and can agree to the study's procedures and risks.My cholesterol levels are high despite taking medication.I am not pregnant and will use effective birth control during the study.I am not pregnant, breastfeeding, nor planning to become pregnant during the study or for 6 months after.I have had surgery or treatment for blocked arteries in my legs.I have inflammatory bowel disease or chronic diarrhea.I am using or will start using long-term steroid pills or injections for my condition.My triglyceride levels are high despite taking medication for it.I have a history of heart issues, including heart attack, angina, or stroke.I haven't had a peptic ulcer or serious stomach bleeding in the last 2 years, except for mild hemorrhoidal bleeding over 5 years ago.I am on long-term blood thinner medication.I haven't used any experimental drugs recently.I am currently taking aspirin or another drug to prevent blood clots.I am being treated for type 2 diabetes according to national guidelines.I am allergic or highly sensitive to aspirin.I am currently using or have used colchicine for conditions like gout or Familial Mediterranean Fever.
- Group 1: Anti-thrombotic arm
- Group 2: Anti-thrombotic arm (Placebo)
- Group 3: Anti-inflammatory arm
- Group 4: Anti-inflammatory arm (Placebo)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
Is Anti-thrombotic arm a viable option for individuals with regards to safety?
"Drawing from prior clinical data, our team at Power gave the Anti-thrombotic arm a rating of 3. This indicates that multiple rounds of research have been conducted to verify its efficacy and safety."
Does this clinical trial have an age restriction for potential participants?
"The target population for this medical study is persons aged between 55 and 80 years old."
Are individuals presently being enrolled in this trial?
"Per clinicaltrials.gov, this research trial is no longer recruiting patients. It was first posted on November 1st 2022 and its last update occurred on the 30th of that same month. Despite being closed to recruitment, 1261 other studies are currently open for patient enrollment."
Which individuals are authorized to take part in this investigation?
"This clinical trial calls for 10,000 patients aged between fifty-five and eighty with cardiovascular conditions. Additional selection criteria includes gender, duration of diabetes, smoking status, hs-CRP levels (≥ 2mg/L), coronary calcium score (>100 Agatston Score), triglyceride levels (≥1.7 mmol/L) despite lipid lowering therapy administered as per guidelines, LDL-C or non-HDL-C levels (4.2mmol/L+) even after the cholesterol medications are used according to protocol and Apo B ≥ 1.05 g/L)."
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