NCT06215989 Treatment of ACuTe Coronary Syndromes With Low-dose colchICine
| NCT ID | NCT06215989 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Anzhen Hospital |
| Condition | Acute Coronary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 6,574 participants |
| Start Date | 2024-09-02 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 6,574 participants in total. It began in 2024-09-02 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Age ≥ 18 years; * Definite diagnosis of ACS; * Ability and willingness to provide written informed consent Exclusion Criteria: * 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 alternative pathology and myocardial necrosis are defined as suffering type 2 myocardial infarction. The classification of type 2 myocardial infarction also includes patients with coronary vasospasm, embolism or spontaneous dissection without evidence of atherothrombosis related to coronary artery disease); * 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 \<100g/L or hematocrit \< 30% or \> 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 normal range or severe liver disease with coagulation disorders(INR\>1.5)(except for elevated glutamic oxalacetic transaminase associated with myocardial infarction); * 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.
Contact & Investigator
Yujie Zhou, PhD, MD
STUDY CHAIR
Beijing Anzhen Hospital
Frequently Asked Questions
Who can join the NCT06215989 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06215989 currently recruiting?
Yes, NCT06215989 is actively recruiting participants. Contact the research team at azzyj12@163.com for enrollment information.
Where is the NCT06215989 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06215989 clinical trial?
NCT06215989 is sponsored by Beijing Anzhen Hospital. The principal investigator is Yujie Zhou, PhD, MD at Beijing Anzhen Hospital. The trial plans to enroll 6,574 participants.