Colchicine use in heart attack patients after percutaneous coronary stenting
- Conditions
- Health Condition 1: I21- Acute myocardial infarctionHealth Condition 2: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarctionHealth Condition 3: I200- Unstable angina
- Registration Number
- CTRI/2022/05/042760
- Lead Sponsor
- PGIMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 180
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.
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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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To find out whether colchicine 0.5mg once daily can safely reduce the composite <br/ ><br>primary endpoint: CV death, myocardial infarction, resuscitated cardiac arrest, ischemic <br/ ><br>stroke, recurrent MI or Urgent hospitalization for angina leading to coronary <br/ ><br>revascularization in patients with CAD undergoing PCI over a <br/ ><br>period of 6 months when compared to placeboTimepoint: 6 months
- Secondary Outcome Measures
Name Time Method To find out whether colchicine 0.5mg once daily can safely reduce the independent <br/ ><br>secondary endpoint: Inflammatory biomarkers (ESR,CRP,hsCRP,albumin,IL- <br/ ><br>6,ferritin,uric acid,fibrinogen) ,LDL cholesterol level and adverse drug events in patients <br/ ><br>of CAD undergoing PCI over a period of 6 months when compared to placeboTimepoint: 6 months