Evaluation of the effect of Colchicine in the patients with Acute Coroanry Syndrome

Evaluation of the effect of Colchicine on incidence of Major Adverse Cardiac Events (MACE) in the patients with Acute Coronary Syndrome (ACS) during the first 6 months of Colchicine use

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201117049420N1

Enrollment

240

Registered

2020-11-22

Start date

2019-09-23

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndrome. ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction

Interventions

Intervention 1: Intervention Group: This group will receive standard treatment of ACS plus 0.5 mg per day Colchicine for 6 months. Intervention 2: Control Group: This group will receive standard treat

Eligibility

Sex/Gender

All

Age

40 Years to 70 Years

Inclusion criteria

Inclusion criteria: Patients who have completed the informed consent form Patients aged 40-70 years with history of chest pain who have undergone Coronary Angiography with the aim of medical treatment or who have undergone Total or Near Total Revascularization Whose information and follow ups are completed

Exclusion criteria

Exclusion criteria: 1. Patients with history of hypersensitivity to Colchicine 2. Patients with history of Moderate Renal Dysfunction (GFR 1.5 * ULN) 4. Patients with history of Thrombocytopenia and or Leukopenia 5. Pregnant patient, Lactating women, and women at risk of Pregnancy 6. Patients who are already taking Colchicine 7. Patients who have undergone CABG (Coronary Artery Bypass Grafting) 8. Patients with LVEF less than 30%

Design outcomes

Primary

Measure	Time frame
Hospitalization due to typical chest pain (Acute Coronary Syndrome). Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Hospitalization due to typical chest pain (Acute Coronary Syndrome) by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.;All Cause Mortality. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess mortality by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.;Stroke. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Stroke by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.;Decompensated Heart Failure. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Decompensated Heart Failure by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.	—

Measure

Time frame

Hospitalization due to typical chest pain (Acute Coronary Syndrome). Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Hospitalization due to typical chest pain (Acute Coronary Syndrome) by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.;All Cause Mortality. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess mortality by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.;Stroke. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Stroke by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.;Decompensated Heart Failure. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Decompensated Heart Failure by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehdi Akrami

Shiraz University of Medical Sciences

akrami.mi@gmail.com+98 71 3228 9696

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026