Cardiovascular disease MedDRA version: 14.1 Level: PT Classification code 10007649 Term: Cardiovascular disorder System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: Aldactone
Product Name: Aldactone
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Potassium canrenoate
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
University College London (UCL)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: •Patients >18 years •Patients presenting with acute STEMI (as assessed by 12 lead ECG;ST segment elevation =2 mm (0.2 mV)in 2 or more contiguous precordial leads or =1mm (0.1mm) in 2 or more adjacent limb leads). •Presentation within 12 hours after symptom onset •Angiographically proven proximal occlusion (TIMI 0) of a major coronary vessel (LAD, LCX, RCA). Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: •Patients with known LVEF =40% prior to randomisation •Cardiogenic shock (catecholamine support OR systolic blood pressure 2 •Prior myocardial infarction •Potassium > 5.0 mmol/l or known renal failure (> CKD III) or porphyria •known impaired liver function or liver failure •Current treatment with mineralocorticoid receptor antagonists •Pregnant or lactating females •Allergies to IMP or its excipients •Known contraindication to cardiac magnetic resonance imaging (MRI) such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as an estimated glomerular filtration rate [eGFR] 2). Patients with known contraindications to treatment with spironolactone.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does the administration of mineralo-corticoid-receptor antagonist (MRA) therapy initiated prior to coronary angioplasty followed by three months MRA therapy reduced the damage to the heart muscle in patients presenting with a heart attack?;Secondary Objective: Secondary endpoints: 1.Several markers of myocardial reperfusion injury angiographical scores, successfull blood flow restoration post angioplasty, resolution of ECG changes after balloon angioplasty) 2.early changes in the heart muscle, as assessed with cardiac MRI 3.Measurement of acute myocardial infarct size (blood markers and cardiac MRI on day 3) 5.Heart size and function on 3 month cardiac MRI scan 6.Clinical outcome measures: cardiovascular death, non-fatal myocardial infarction, for heart failure, hyperkalemia, deterioration of kidney function, need for dialysis.;Primary end point(s): Myocardial infarct (scar) size 3 months after a heart attack, as assessed with CMR.;Timepoint(s) of evaluation of this end point: Myocardial infarct (MI) size, as assessed by cardiac magnetic resonance imaging 12 weeks after an acute STEMI. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): In the case of secondary endpoint Fisher’s exact test is used to compare categorical variables.;Timepoint(s) of evaluation of this end point: Continuous variables will be compared with a mixed effects model to account for repeated measures. Time-to-event analyses (secondary clinical endpoints), based on all available follow-up data, will be performed with the use of Kaplan–Meier estimates and be compared between groups with the use of the log-rank test. | — |
Countries
United Kingdom
Contacts
Public ContactDerek Hausenloy
Hatter Cardiovascular Institute
Outcome results
None listed