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

Phase 3

• Conditions: Reperfusion Injury, Myocardial
• Interventions: Drug: Placebo (lactose); Drug: Colchicine

• Registration Number: NCT05734612
• Lead Sponsor: Indonesia University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-12-04
• Study First Submitted: 2023-01-11
• Status Verified: 2023-02
• Study First Submitted QC: 2023-02-08
• Last Update Submitted: 2023-02-08
• Study First Posted: 2023-02-21
• Last Update Posted: 2023-02-21
• Primary Completion: 2023-03-31
• Study Completion: 2023-03-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo (lactose)	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.
Colchicine	Colchicine	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.

Primary Outcome Measures

Name	Time	Method
The Rate of Myocardial Reperfusion Injury	Up to 3 days after primary percutaneous coronary intervention	The rate of hypotension, acute heart failure, arrhythmias, persistent chest pain, or microvascular obstruction up to 3 days after primary percutaneous coronary intervention after primary percutaneous coronary intervention

Secondary Outcome Measures

Name	Time	Method
Activation of NLRP3 in peripheral blood vein measured in counts	30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention	Activation of NLRP3 in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention measured in counts
Concentration of ASC in peripheral blood vein in ng/ml	30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention	Concentration of ASC in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in ng/ml
Concentration of caspase in peripheral blood vein in pg/ml	30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention	Concentration of caspase in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in pg/ml
Concentration of troponin in peripheral blood vein in ng/L	30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention	Concentration of troponin in peripheral blood vein 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention in ng/L

Trial Locations

Locations (1)

Fakultas Kedokteran Universitas Indonesia; 🇮🇩 Jakarta Pusat, Jakarta, Indonesia