The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury

University of Indonesia (UI)

Status and phase: Invitation-only; Phase 3

Conditions: Reperfusion Injury, Myocardial

Treatments: Drug: Placebo (lactose); Drug: Colchicine

Study type: Interventional

Funder types: Other

Identifiers

NCT05734612

22-09-1046

Details and patient eligibility

About

The goal of this clinical trial is to investigate the role of colchicine in reducing the rate of myocardial reperfusion injury in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention. The main questions it aims to answer are:

• Does colchicine reduce the rate of myocardial reperfusion injury ?
• Does colchicine reduce the concentration of markers of myocardial reperfusion injury (NLRP3, ASC, caspase, and troponin) ?

Participants will

• Be grouped into intervention group and control group blindly. Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days. Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.
• Undergo peripheral blood vein examination before primary percutaneous coronary intervention, after primary percutaneous coronary intervention, 24 hour after primary percutaneous coronary intervention, and 48 hour after primary percutaneous coronary intervention.

Researchers will compare intervention group and control group to see if colchicine reduces the rate of myocardial reperfusion injury and reduces the concentration of markers of myocardial reperfusion injury (NLRP3, ASC, caspase, and troponin) in patients with ST-elevation myocardial infarction after primary percutaneous coronary intervention.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with ST-elevation myocardial infarction based on clinical symptoms, signs, and electrocardiography who undergo primary percutaneous coronary intervention
• Patients aged 18 - 80 years old

Exclusion criteria

• Patients with malignancy
• Patients with allergic reaction to colchicine
• Stroke within the last 3 months
• Severe infection (sepsis)
• Chronic kidney disease with eGFR of <30mL/min/1.73m2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

80 participants in 2 patient groups, including a placebo group

Colchicine

Experimental group

Description:

Patients in the intervention group receive loading dose of colchicine 1 x 2 mg followed by colchicine 2 x 0,5 mg daily for two consecutive days.

Treatment:

Drug: Colchicine

Placebo

Placebo Comparator group

Description:

Patients in the control group receive loading dose of placebo (lactose) 1 x 2 mg followed by lactose 2 x 0,5 mg daily for two consecutive days.

Treatment:

Drug: Placebo (lactose)