Health Condition 1: I21- Acute myocardial infarction Health Condition 2: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Health Condition 3: I200- Unstable angina
Conditions
Interventions
Intervention1: colchicine: Tablet.Colchicine 0.5 mg 1 OD for 6 months
Control Intervention1: Placebo: Tablet.Placebo 1 OD for 6 months
Sponsors
PGIMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Those who give consent for participation in study. 2.Age >18 years and<85 years 3. Proven coronary disease; as evidenced by coronary angiography, CT angiography or a Coronary Artery Calcium Score > 400 Agatston Units. 36 4. Individuals with a history of coronary artery bypass surgery are only eligible if they had undergone bypass surgery more than 10 years before or have angiographic evidence of graft failure or have undergone coronary intervention since their bypass surgery 5.Newly diagnosed ACS (UA,STEMI,NSTEMI) undergoing PCI 6. Patient undergone PTCA within a month
Exclusion criteria
Exclusion criteria: 1.Patients not willing for follow up. 2. Patients who are refusing to give informed consent 3. Patients <18 years of age 4.Women who are pregnant, breastfeeding or may be considering pregnancy during the study period 5.Patients with renal impairment: serum creatinine >1.5mg/dl or eGFR <45mL/min or on dialysis 6. Patients with heart failure with NYHA Class 3 or 4 7. Patients with valvular heart disease considered likely to require intervention 8. Patients who is dependent or frail or have a life expectancy < 6 months 9. Patients with peripheral neuritis, myositis or marked myosensitivity to statins 10. Patients who already taking long-term colchicine therapy for any other reason 11.Stroke within the last 3 months 12.Coronary artery bypass surgery within the last 3 years 13.Cancer within the last 3 years 14. Patients with known history of inflammatory bowel disease or chronic diarrhea, cirrhosis, drug abuse, or sensitivity to colchicine 15.Hematological malignancy, thrombocytopenia, leucopenia 16. Use of oral steroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find out whether colchicine 0.5mg once daily can safely reduce the composite primary endpoint: CV death, myocardial infarction, resuscitated cardiac arrest, ischemic stroke, recurrent MI or Urgent hospitalization for angina leading to coronary revascularization in patients with CAD undergoing PCI over a period of 6 months when compared to placeboTimepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To find out whether colchicine 0.5mg once daily can safely reduce the independent secondary endpoint: Inflammatory biomarkers (ESR,CRP,hsCRP,albumin,IL- 6,ferritin,uric acid,fibrinogen) ,LDL cholesterol level and adverse drug events in patients of CAD undergoing PCI over a period of 6 months when compared to placeboTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactProfessor Yash paul sharma
Post graduate institute of medical education and research, Chandigarh.
Outcome results
None listed