Blocking the lethal effects of aldosterone in myocardial infarction treated or not by reperfusion to improve prognosis and six-month survival: A randomized study comparing specific aldosterone blockade in addition to usual therapy with usual therapy alone initiated within the first 72 hours after the onset of acute myocardial infarction "ALBATROSS"

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Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: ALDACTONE Product Name: ALDACTONE Pharmaceutical Form: Buccal tablet INN or Proposed INN: SPIRONOLACTONE CAS Number: 52‐01‐7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: Cp/25 mg‐ Trade Name: SOLUDACTONE Product Name: SOLUDACTONE Pharmaceutical Form: Solution for injection INN or Proposed INN: Canrenoate potassium CAS Number: 2181‐04‐6 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200 mg‐ CONDITION: Infractus; MedDRA version: 8.1 Level: PT Classification code 10000891 Term: IMC PRIMARY OUTCOME: Main Objective: 1. Main objective; To demonstrate that early intravenous administration of a selective aldosterone inhibitor within the first 72 hours after myocardial infarction, followed by oral treatment for 6 months, in addition to standard therapy with or without myocardial reperfusion, compared to standard therapy alone, is associated with a reduction in major adverse events over 6 months. Primary endpoint(s): 1. Primary endpoint; This is a composite endpoint over a 6-month period, combining the incidence of: - death; - sudden resuscitated death; - life-threatening arrhythmias (VF, significant VT); - indication for an implantable defibrillator or the onset or worsening of heart failure. 2. Secondary endpoints; - Each of the criteria of the primary endpoint; Death; Sudden resuscitated death; Significant VF/VT; Heart failure; - Combined criteria; Death + sudden resuscitated death; Death + sudden resuscitated death + VF + VT; Death + sudden resuscitated death + VT + VF + defibrillator indication, VF + VT; Death + Heart failure; - Acute renal failure; - Other criteria; Recurrent myocardial infarction; Ischemic recurrence (proven by electrical changes or re-ascension of markers); Emergency revascularization (other than initial reperfusion); Any revascularization (other than initial reperfusion); Safety and tolerability criteria; Secondary Objective: To demonstrate that early intravenous administration of a selective aldosterone inhibitor, within the first 72 hours after the onset of myocardial infarction, followed by oral treatment for 6 months, in addition to usual treatment with or without myocardial reperfusion, compared with usual treatment alone, is associated with a reduction in major clinical events during the hospital phase, and for 30 days. INCLUSION CRITERIA: 1- Patients aged 18 years and older 2- Ischemic symptom lasting more than 20 minutes 3- The symptom occurred within 72 hours prior to randomization 4- ECG and/or biological signs of acute myocardial infarction 5- Patient affiliated with a social security scheme (beneficiary or dependent) 6- Obtaining consent: a)- Signature of informed consent if the patient is capable of giving it b)- Otherwise, obtaining consent from family members or the designated representative if present Notes: * All Killip classes at admission and patients with a history of coronary artery bypass grafting are eligible Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no.
Epistemonikos ID: 64f6feeebcf68702f43925b7ab4999a490122927
First added on: Jul 27, 2021
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