Actively Recruiting
Treatment of Acute Coronary Syndromes With Low-dose Colchicine (TACTIC): A Randomized, Double-blinded, Placebo-controlled, Multicentric Trial
Led by Beijing Anzhen Hospital · Updated on 2024-10-30
6574
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether adding low-dose colchicine to standard guideline-recommended treatment can further reduce the risk of major adverse cardiovascular events in adults with acute coronary syndromes (ACS). This randomized, double-blind, placebo-controlled trial aims to clarify the effects of colchicine, an oral anti-inflammatory drug, on cardiovascular outcomes after ACS, as current studies have not fully determined its benefit in this setting. The study is sponsored by Beijing Anzhen Hospital and follows updated guidelines that recommend colchicine for secondary prevention in chronic stable coronary artery disease. Participants diagnosed with ACS are randomly assigned within 48 hours to receive either standard treatment plus colchicine (0.5mg once daily) or standard treatment plus a placebo tablet once daily. Both treatments begin from the first month after randomization and continue for 12 months. The primary outcome measured is a combination of cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous myocardial infarction, readmission for ACS, and unplanned revascularization during the first year. During the study, participants will be monitored regularly to assess these cardiovascular events and other secondary endpoints at one year. Researchers will also track adherence to the study medication and evaluate safety. The total participation duration includes one year of treatment and follow-up to observe the effects of colchicine compared to placebo alongside standard care for ACS.
CONDITIONS
Brief Title
Treatment of ACuTe Coronary Syndromes With Low-dose colchICine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Definite diagnosis of acute coronary syndrome (ACS)
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Type 2 myocardial infarction or related conditions such as coronary vasospasm, embolism, or spontaneous dissection without atherothrombosis
- Valvular heart disease likely requiring surgery
- History of non-skin cancer within the past 3 years
- Inflammatory bowel disease or chronic diarrhea
- History of gastric ulcer or previous gastric bleeding
- Neuromuscular diseases or persistently elevated creatine kinase levels
- Significant persistent blood abnormalities (low hemoglobin, abnormal hematocrit, low white blood cell or platelet counts)
- Severe kidney impairment (eGFR below 30 mL/min/1.73m2)
- Severe liver disease with coagulation disorders or elevated liver enzymes combined with high bilirubin
- Cognitive decline impairing independent daily living activities
- Drug or alcohol abuse
- Current or planned immunosuppressive therapies
- Other reasons requiring long-term colchicine treatment
- History of colchicine allergy or suspected allergy
- Use of strong CYP3A4 or P-glycoprotein inhibitors without alternative drugs available
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 11 months
Participants receive standard treatment for acute coronary syndrome plus either low-dose colchicine or placebo daily from the 1st month to the 12th month after randomization.
Visits as per standard care plus study visits during treatment
Trial Site Locations
Total: 1 location
1
Beijing Anzhen Hospital
Beijing, Beijing Municipality, China, 100029
Actively Recruiting
Research Team
Y
Yujie Zhou, PhD, MD
X
Xiaoteng Ma, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here