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IRCT20201117049420N1 IRCT 2020-11-22 Shiraz University of Medical Sciences Evaluation of the effect of Colchicine in the patients with Acute Coroanry Syndrome Evaluation of the effect of Colchicine on incidence of Major Adverse Cardiac Events (MACE) in the patients with Acute Coronary Syndrome (ACS) during the first 6 months of Colchicine use 2019-09-23 anticipated 240 Complete https://irct.ir/trial/52355 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The permutation block randomization method with four blocks will be used. This method is one of the most widely used random methods that largely guarantees equality of groups. To do this, we first name the groups A, B and there are 4 different placements of these two letters, of course, blocks of 2, 6, etc. can also be considered. But blocks of 4 are used more often. The four permutations of the two letters A, B are AABB, ABAB, ABBA, BBAA, BABA, BAAB. Each of these is a block of size 4 that contains two experimental and two control groups, such as the AABB permutation, meaning that of the four selected individuals, the first and the second group A (group A can be a test or a control) and The second two belong to group B (group B can be a test or a control randomly by throwing a coin to determine which test A and B are to be tested and, for example, suppose that experiment A and control B are selected). We assign these 6 permutations to the numbers 1 through 6 as follows. 1. AABB 2. ABAB 3. ABBA 4. BBAA 5. BABA 6. BAAB By using the random number table, we extract numbers from the table, and depending on the number of randomly extracted numbers that are one of the numbers 0 to 9 and depending on whether one of the numbers is 1 to 6, each block We choose the number assigned to these numbers, select each of the blocks assigned to these numbers, so that 60 blocks of the four are selected. If the numbers are 0, 7, 8, and 9, we will exclude it and continue this order to provide a complete list for the whole sample size. (Randomization can also be done using a computer): 0001: study 0002: control 0003: control 0004: study 0005: study 0006: control 0007: control 0008: study 0009: control 0010: study 0011: control 0012: study 0013: study 0014: control 0015: study 0016: control 0017: study 0018: control 0019: control 0020: study 0021: study 0022: control 0023: control 0024: study 0025: control 0026: study 0027: control 0028: study 0029: study 0030: control 0031: study 0032: control 0033: study 0034: control 0035: control 0036: study 0037: study 0038: control 0039: control 0040: study 0041: control 0042: study 0043: control 0044: study 0045: study 0046: control 0047: study 0048: control 0049: study 0050: control 0051: control 0052: study 0053: study 0054: control 0055: control 0056: study 0057: control 0058: study 0059: control 0060: study 0061: study 0062: control 0063: study 0064: control 0065: study 0066: control 0067: control 0068: study 0069: study 0070: control 0071: control 0072: study 0073: control 0074: study 0075: control 0076: study 0077: study 0078: control 0079: study 0080: control 0081: study 0082: control 0083: control 0084: study 0085: study 0086: control 0087: control 0088: study 0089: control 0090: study 0091: control 0092: study 0093: study 0094: control 0095: study 0096: control 0097: study 0098: control 0099: control 0100: study 0101: control 0102: study 0103: study 0104: control 0105: control 0106: control 0107: study 0108: study 0109: control 0110: control 0111: study 0112: study 0113: study 0114: control 0115: study 0116: control 0117: control 0118: study 0119: study 0120: control 0121: control 0122: control 0123: study 0124: study 0125: control 0126: control 0127: study 0128: study 0129: study 0130: control 0131: study 0132: control 0133: control 0134: study 0135: study 0136: control 0137: control 0138: control 0139: study 0140: study 0141: control 0142: control 0143: study 0144: study 0145: study 0146: control 0147: study 0148: control 0149: control 0150: study 0151: study 0152: control 0153: control 0154: control 0155: study 0156: study 0157: control 0158: control 0159: study 0160: study 0161: study 0162: control 0163: study 0164: control 0165: control 0166: study 0167: study 0168: control 0169: control 0170: control 0171: study 0172: study 0173: control 0174: control 0175: study 0176: study 0177: study 0178: control 0179: study 0180: control 0181: control 0182: study 0183: study 0184: control 0185: control 0186: control 0187: study 0188: study 0189: control 0190: control 0191: study 0192: study 0193: study 0194: control 0195: study 0196: control 0197: control 0198: study 0199: study 0200: control 0201: control 0202: control 0203: study 0204: study 0205: control 0206: control 0207: study 0208: study 0209: study 0210: control 0211: study 0212: control 0213: control 0214: study 0215: study 0216: control 0217: control 0218: control 0219: study 0220: study 0221: control 0222: control 0223: study 0224: study 0225: study 0226: control 0227: study 0228: control 0229: control 0230: study 0231: study 0232: control 0233: control 0234: control 0235: study 0236: study 0237: control 0238: control 0239: study 0240: study 0241: study 0242: control 0243: study 0244: control The researcher who reviews the results is not aware of the group allocation, Blinding description: 1. Patients will blind as to whether or not they were given placebo 2. Person who follows up the patients by phone is blind as to which patients were given placebo or Colchicine 3.Statistical Analyzer is blind to patients assignment to either group. 3 Acute Coronary Syndrome. Intervention 1: Intervention Group: This group will receive standard treatment of ACS plus 0.5 mg per day Colchicine for 6 months. Intervention 2: Control Group: This group will receive standard treatment of ACS plus Placebo for 6 months. Yes - There is a plan to make this available What will be shared: All data of study participants can be shared after unidentified individuals When: Access period starts 6 months after the results are published To whom: The data will be available only to researchers working in academic and scientific institutions Conditions: The data will be provided to researchers only to verify its accuracy Where to obtain: Applicants can send their request via the following email: akrami.mi@gmail.com How to obtain: The applicant must confirm his / her identity by e-mail, and after confirming his / her identity, he / she must send a formal request from his / her institution to the address which will be sent to him / her by mail. Then, after receiving their request by mail, the requested Data will be sent within 3 months Comments:
public Mehdi Akrami
Unit 9, No. 9, Amir Bldg, Alley11, Abolkalam Sq
Shiraz Iran (Islamic Republic of) 7146658388 +98 71 3228 9696 akrami.mi@gmail.com Shiraz University of Medical Sciences scientific Mehdi Akrami
Unit 9, no. 9, Amir Bldg, Alley 11, Abolkalam Sq
Shiraz Iran (Islamic Republic of) 7146658388 +98 71 3228 9696 akrami.mi@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients who have completed the informed consent form Patients aged 40-70 years with history of chest pain who have undergone Coronary Angiography with the aim of medical treatment or who have undergone Total or Near Total Revascularization Whose information and follow ups are completed 40 years 70 years Both 1. Patients with history of hypersensitivity to Colchicine 2. Patients with history of Moderate Renal Dysfunction (GFR<50) 3. Patients with history of Hepatic Dysfunction (ALT> 1.5 * ULN) 4. Patients with history of Thrombocytopenia and or Leukopenia 5. Pregnant patient, Lactating women, and women at risk of Pregnancy 6. Patients who are already taking Colchicine 7. Patients who have undergone CABG (Coronary Artery Bypass Grafting) 8. Patients with LVEF less than 30% I21 ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction Treatment - Drugs Placebo Intervention Group: This group will receive standard treatment of ACS plus 0.5 mg per day Colchicine for 6 months Control Group: This group will receive standard treatment of ACS plus Placebo for 6 months All Cause Mortality. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess mortality by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents. Stroke. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Stroke by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents. Decompensated Heart Failure. Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Decompensated Heart Failure by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents. Hospitalization due to typical chest pain (Acute Coronary Syndrome). Timepoint: We will follow up all patients 7 days after discharge from the hospital and then monthly to assess Hospitalization due to typical chest pain (Acute Coronary Syndrome) by telephone. They will also be visited every two months. Method of measurement: Questioning the patient and the patient,s visitor; and reviewing the patient's documents. Shiraz University of Medical Sciences Approved 2019-09-23 Ethics committee of Shiraz University of Medical Sciences Ethics committee of Shiraz University of Medical Sciences, Zand Blvd Shiraz Fars Iran (Islamic Republic of)