MINeralocorticoid receptor antagonist pretreatment to MINIMISE reperfusion injury after ST-Elevation Myocardial Infarction (STEMI)

Phase 1

• Conditions: Cardiovascular disease; MedDRA version: 14.1Level: PTClassification code 10007649Term: Cardiovascular disorderSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-001069-18-GB
• Lead Sponsor: niversity College London (UCL)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-06
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

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

•Patients with known LVEF =40% prior to randomisation •Cardiogenic shock (catecholamine support OR systolic blood pressure < 90 mmHg) •Killip class > 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] <30 mL/min/1.73 m2, known from previous examinations), presence of MRI contraindicated implanted devices (eg, pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), imbedded metal objects (eg, shrapnel), or any other contraindication for cardiac MRI Once the current serum creatinine is known, patients with severely compromised renal function (eGFR < 30 ml/min/1.73 m2) will also be excluded. Patients with known porphyria. Patients with significant liver dysfunction (INR>2). Patients with known contraindications to treatment with spironolactone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified