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New treatment option for Acute Coronary Syndrome
Official title Treatment of ACuTe Coronary Syndromes With Low-dose colchICine
ClinicalTrials.gov ID: NCT06215989
What this study is testing
What is Colchicine Pill?
Colchicine Pill is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for acute coronary syndrome.
Also referred to as Colchicine 0.5 MG.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This trial is designed to evaluate whether low-dose colchicine, in addition to standard treatment recommended by guidelines, further reduces the risk of major adverse cardiovascular events in patients with acute coronary syndromes (ACS) through a prospective, randomized, double-blind, placebo-controlled clinical trial.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥ 18 years;
- Definite diagnosis of ACS;
- Ability and willingness to provide written informed consent
You likely can't join if
- Type 2 myocardial infarction (Patients with symptoms or signs of myocardial ischemia and evidence of increased oxygen demand or decreased supply [for...
- Valvular heart disease that is considered likely to require surgical intervention;
- History of non-skin cancer in the past 3 years;
- Inflammatory bowel disease or chronic diarrhea;
- History of gastric ulcer or previous gastric bleeding;
- Neuromuscular diseases or non-transient (At least 2 laboratory tests) creatine kinase levels greater than 3 times the upper limit of the normal range...
See the full eligibility criteria
- Age ≥ 18 years;
- Definite diagnosis of ACS;
- Ability and willingness to provide written informed consent
- Type 2 myocardial infarction (Patients with symptoms or signs of myocardial ischemia and evidence of increased oxygen demand or decreased supply [for example, tachyarrhythmia, hypotension, or anaemia] secondary to an...
- Valvular heart disease that is considered likely to require surgical intervention;
- History of non-skin cancer in the past 3 years;
- Inflammatory bowel disease or chronic diarrhea;
- History of gastric ulcer or previous gastric bleeding;
- Neuromuscular diseases or non-transient (At least 2 laboratory tests) creatine kinase levels greater than 3 times the upper limit of the normal range (except those associated with myocardial infarction);
- Clinically significant non-transient (At least 2 laboratory tests) blood abnormalities(Hemoglobin \ 52% or white blood cell count \< 3×109/L or platelet count \< 100×109/L);
- Estimated glomerular filtration rate (eGFR)\<30mL/min/1.73m2 (based on CKD-EPI formula);
- Serum alanine aminotransferase and/or aspartate aminotransferase levels greater than 2 times the upper limit of the normal range accompanied by serum total bilirubin levels greater than 2 times the upper limit of the...
- Decline in cognitive function due to inability to perform basic activities of daily living independently;
- Drug or alcohol abuse;
- Other immunosuppressive therapies already in existence or planned;
- Other causes require long-term colchicine treatment;
- History of clear or suspected colchicine allergy;
- Strong CYP3A4 or P-glycoprotein inhibitors (such as cyclosporine, antiretrovirals, antifungals, erythromycin and clarithromycin) have been used and no other alternative drugs can be used.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.