NCT05734612

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

Status unknown Phase 3 Last updated 21 February 2023

What this trial tests

Phase 3 trial testing Colchicine in Reperfusion Injury, Myocardial in 80 participants. Status unknown.

Timeline

4 December 2022

Primary endpoint
31 March 2023

31 March 2023

Quick facts

Lead sponsor	Indonesia University
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	80
Start date	4 December 2022
Primary completion	31 March 2023
Estimated completion	31 March 2023
Sites	1 location across Indonesia

Drugs / interventions tested

• Colchicine (COLCHICINE) — full drug profile →
• Placebo (lactose)

Conditions studied

• Reperfusion Injury, Myocardial — all drugs for Reperfusion Injury, Myocardial →

Sponsor

Indonesia University

Who can join

Adults 18 to 80, any sex, with Reperfusion Injury, Myocardial. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. The role of inflammasomes in human diseases and their potential as therapeutic targets.
   Yao J, Sterling K, Wang Z, Zhang Y, et al · · 2024 · cited 135× · PMID 38177104 · DOI 10.1038/s41392-023-01687-y
2. NLRP3 inflammasome: a key player in the pathogenesis of life-style disorders.
   Ramachandran R, Manan A, Kim J, Choi S. · · 2024 · cited 67× · PMID 38945951 · DOI 10.1038/s12276-024-01261-8
3. Nucleotide-binding domain, leucine-rich repeat, and pyrin domain-containing protein 3 inflammasome: From action mechanism to therapeutic target in clinical trials.
   Zhang CY, Liu S, Sui YX, Yang M. · · 2025 · cited 1× · PMID 39958558 · DOI 10.4251/wjgo.v17.i2.100094
4. The NLRP3 Inflammasome: Mechanisms of Activation, Regulation, and Therapeutic Opportunities.
   Zou C, Jiang S, Li H, Zhao K, et al · · 2026 · PMID 41799937 · DOI 10.1002/mco2.70660
5. Cardioprotective therapies for ST-elevation myocardial infarction: the emerging role of thyroid hormone: a narrative review.
   Grigoriou K, Karakasis P, Lamprou V, Michas G, et al · · 2025 · PMID 41473237 · DOI 10.3389/fendo.2025.1696749
6. Inflammasomes in lymphocytes as therapeutic targets.
   Albakova Z. · · 2025 · PMID 40054124 · DOI 10.1016/j.tranon.2025.102342