Treatment of ACuTe Coronary Syndromes With Low-dose colchICine

NCT06215989 | Recruiting DMC

• 1 other identifier: TACTIC
• Study Type: interventional
• Target: 6,574
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Coronary Syndrome; Unstable Angina; ST Elevation Myocardial Infarction; Non ST Segment Elevation Myocardial Infarction; Colchicine

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  Rate of the composite of cardiovascular death, non-fatal ischemic stroke, non-fatal spontaneous (non-operation related) myocardial infarction, readmission for ACS, and ischaemia driven (unplanned) revascularization

  1 year after randomization

Secondary Outcomes (8)

• Key secondary endpoint

  1 year after randomization

• Secondary endpoint 1

  1 year after randomization

• Secondary endpoint 2

  1 year after randomization

• Secondary endpoint 3

  1 year after randomization

• Secondary endpoint 4

  1 year after randomization

Study Arms (2)

Colchicine group

EXPERIMENTAL

Patients are randomized within 48 hours after diagnosis of ACS, and on the day of randomization, eligible patients undergo standard treatment plus colchicine (0.5mg qd from 1st month to 12th month).

Drug: Colchicine Pill

Placebo group

PLACEBO COMPARATOR

Patients are randomized within 48 hours after diagnosis of ACS, and on the day of randomization, eligible patients undergo standard treatment plus placebo (1 tablet qd from 1st month to 12th month).

Drug: Placebo

Interventions

Colchicine Pill DRUG

Colchicine 0.5mg once daily will be given on the basis of standard treatment of ACS recommended by guidelines

Also known as: Colchicine 0.5 MG

Colchicine group

Placebo DRUG

Placebo one tablet once daily will be given on the basis of standard treatment of ACS recommended by guidelines

Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years;
• Definite diagnosis of ACS;
• Ability and willingness to provide written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Anzhen Hospital: lead

Study Sites (1)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Angina, Unstable; ST Elevation Myocardial Infarction

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Yujie Zhou, PhD, MD

  Beijing Anzhen Hospital

  STUDY CHAIR

• Xiaoli Liu, PhD, MD

  Beijing Anzhen Hospital

  STUDY DIRECTOR

• Xiaoteng Ma, MD

  Beijing Anzhen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Zhou, PhD, MD

CONTACT

8613901330652; azzyj12@163.com

Xiaoteng Ma, MD

CONTACT

8618810616459; maxiaotengai@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: October 30, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)