The Role of Colchicine in Reducing The Rate of Myocardial Reperfusion Injury in Patients With ST-Elevation Myocardial Infarction After Primary Percutaneous Coronary Intervention: Study on NLRP3, ASC, Caspase, and Troponin
| Registry | NCT05734612 |
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| Status | Unknown |
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| Phase | Phase 3 |
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| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
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| Enrollment | 80 (Estimated) |
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| Sponsor | Universitas Indonesia (Other) |
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| Conditions | Reperfusion Injury, Myocardial |
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| Interventions | Colchicine, Placebo (lactose) (Drug) |
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| Dates | start 2022-12-04, primary completion 2023-03-31 (estimated), completion 2023-03-31 (estimated), first posted 2023-02-21, last updated 2023-02-21 |
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| Locations | 1 site in Indonesia |
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Related Papers Related Patents Related Grants Related Experts
All trials for Reperfusion Injury, Myocardial All trials of Colchicine All trials of Placebo (lactose)
-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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Colchicine | Experimental | Drug: 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. |
| Placebo | Placebo comparator | Drug: 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 (Drug): 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.
- Placebo (lactose) (Drug): 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.
+Outcome measures
Primary outcomes
- 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 outcomes
- 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
+Eligibility
Sex: All, ages: 18 Years to 80 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat, Jakarta Special Capital Region | Indonesia | |
+Publications
- Deftereos S, Giannopoulos G, Angelidis C, Alexopoulos N, Filippatos G, Papoutsidakis N, Sianos G, Goudevenos J, Alexopoulos D, Pyrgakis V, Cleman MW, Manolis AS, Tousoulis D, Lekakis J. Anti-Inflammatory Treatment With Colchicine in Acute Myocardial Infarction: A Pilot Study. Circulation. 2015 Oct 13;132(15):1395-403. doi: 10.1161/CIRCULATIONAHA.115.017611. Epub 2015 Aug 11. PMID 26265659
- Akodad M, Lattuca B, Nagot N, Georgescu V, Buisson M, Cristol JP, Leclercq F, Macia JC, Gervasoni R, Cung TT, Cade S, Cransac F, Labour J, Dupuy AM, Roubille F. COLIN trial: Value of colchicine in the treatment of patients with acute myocardial infarction and inflammatory response. Arch Cardiovasc Dis. 2017 Jun-Jul;110(6-7):395-402. doi: 10.1016/j.acvd.2016.10.004. Epub 2017 Jan 3. PMID 28065445
- Mewton N, Roubille F, Bresson D, Prieur C, Bouleti C, Bochaton T, Ivanes F, Dubreuil O, Biere L, Hayek A, Derimay F, Akodad M, Alos B, Haider L, El Jonhy N, Daw R, De Bourguignon C, Dhelens C, Finet G, Bonnefoy-Cudraz E, Bidaux G, Boutitie F, Maucort-Boulch D, Croisille P, Rioufol G, Prunier F, Angoulvant D. Effect of Colchicine on Myocardial Injury in Acute Myocardial Infarction. Circulation. 2021 Sep 14;144(11):859-869. doi: 10.1161/CIRCULATIONAHA.121.056177. Epub 2021 Aug 23. PMID 34420373
- Vaidya K, Martinez G, Patel S. The Role of Colchicine in Acute Coronary Syndromes. Clin Ther. 2019 Jan;41(1):11-20. doi: 10.1016/j.clinthera.2018.07.023. Epub 2018 Sep 2. PMID 30185392
- Raju NC, Yi Q, Nidorf M, Fagel ND, Hiralal R, Eikelboom JW. Effect of colchicine compared with placebo on high sensitivity C-reactive protein in patients with acute coronary syndrome or acute stroke: a pilot randomized controlled trial. J Thromb Thrombolysis. 2012 Jan;33(1):88-94. doi: 10.1007/s11239-011-0637-y. PMID 21918905
- Robertson S, Martinez GJ, Payet CA, Barraclough JY, Celermajer DS, Bursill C, Patel S. Colchicine therapy in acute coronary syndrome patients acts on caspase-1 to suppress NLRP3 inflammasome monocyte activation. Clin Sci (Lond). 2016 Jul 1;130(14):1237-46. doi: 10.1042/CS20160090. Epub 2016 Apr 21. PMID 27129183
- Vaidya K, Arnott C, Martinez GJ, Ng B, McCormack S, Sullivan DR, Celermajer DS, Patel S. Colchicine Therapy and Plaque Stabilization in Patients With Acute Coronary Syndrome: A CT Coronary Angiography Study. JACC Cardiovasc Imaging. 2018 Feb;11(2 Pt 2):305-316. doi: 10.1016/j.jcmg.2017.08.013. Epub 2017 Oct 18. PMID 29055633
- Results publication: Martinez GJ, Robertson S, Barraclough J, Xia Q, Mallat Z, Bursill C, Celermajer DS, Patel S. Colchicine Acutely Suppresses Local Cardiac Production of Inflammatory Cytokines in Patients With an Acute Coronary Syndrome. J Am Heart Assoc. 2015 Aug 24;4(8):e002128. doi: 10.1161/JAHA.115.002128. PMID 26304941
+Investigators
- Birry Karim, Principal investigator, Fakultas Kedokteran Universitas Indonesia