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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:
Participants will
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colchicine | Experimental | 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 | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Rate of Myocardial Reperfusion Injury | 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 | Up to 3 days after primary percutaneous coronary intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Activation of NLRP3 in peripheral blood vein measured in counts | 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 | 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Birry Karim | Fakultas Kedokteran Universitas Indonesia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fakultas Kedokteran Universitas Indonesia | Jakarta Pusat | Jakarta Special Capital Region | 10430 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26265659 | Background | 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. | |
| 28065445 |
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| ID | Term |
|---|---|
| D015428 | Myocardial Reperfusion Injury |
| ID | Term |
|---|---|
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D017202 | Myocardial Ischemia |
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| ID | Term |
|---|---|
| D003078 | Colchicine |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
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Participants will be grouped into two groups which are intervention group and control group. 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.
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Colchicine and placebo (lactose) will be packed in capsules with the same appearance by the pharmacist. The pharmacist will code the capsules containing colchicine or the capsules containing placebo into group A or group B without informing the participant, care provider, investigator, and outcome assessor regarding the content of each group of capsules. Participant, care provider, investigator, and outcome assessor do not know the content of the capsules given to the participants.
| 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. |
|
| Concentration of ASC in peripheral blood vein in ng/ml | 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 | 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention |
| Concentration of caspase in peripheral blood vein in pg/ml | 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 | 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention |
| Concentration of troponin in peripheral blood vein in ng/L | 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 | 30 minutes before, 30 minutes after, 24 hours after, and 48 hours after primary percutaneous coronary intervention |
| Background |
| 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. |
| 34420373 | Background | 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. |
| 30185392 | Background | 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. |
| 21918905 | Background | 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. |
| 27129183 | Background | 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. |
| 29055633 | Background | 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. |
| 26304941 | Result | 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. |
| D014652 |
| Vascular Diseases |
| D015427 | Reperfusion Injury |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |