REMODEL-AMI

Phase 1

• Conditions: Verify the efficacy of early administration of eplerenone in relation to the development of pathological remodeling of the myocardium in patients after myocardial infarction.; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2014-005407-24-CZ
• Lead Sponsor: IKEM

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-06
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. At least 18 years old
2. Have an ischemic symptom of >20 min within 24 hours before randomization
3. At least one of the following indicator of AMI:
· ST-segment elevation =0.2 mV in at least 2 contiguous precordial leads
· ST-segment elevation =0.1 mV in at least 2 contiguous limb leads
· New or undated left bundle branch block
· Q waves in at least 2 contiguous precordial leads (excluding V1 and avr) not known to be old
· Troponin levels =3 times the upper local limit of normal and in case of NSTEMI, a Thrombolysis In Myocardial Infarction19 score =3
4. Written informed consent provided by the patient
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

• Cardiopulmonary instability
• Killip score=3
• persistent atrial fibrillation with planned rate control therapy
• serum creatinine> 220 umol / L for men and> 177 umol / L for women
• serum potassium> 5.0 mmol / L
• anticipated early aorto-coronary bypass or valve surgery
• anticipated early pacemaker implantation or cardioverter-defibrillator
• contraindications to perform MR (implanted pacemaker, defibrillator, or neurostimulator; the presence of foreign material in the body of uncertain origin or with known incompatibility with MR tomograph; implantation of coronary stents other than the Promus Element-Boston Scientific, Orsiro-Biotronic, RESOLUT Integrity Medtronic; extreme overweight; the claustrophobia)
• age <18 years
• pregnancy, lactation
• premenopausal women who are not willing to use an effective form of contraception
• absence of consent to inclusion in the study
• clinically relevant polymorbidity
• assumption noncompliance
• Hypersensitivity to the active substance or to any of the excipients
• Patients with moderate to severe renal insufficiency (creatinine clearance <50 ml / min or serum creatinine levels above 220 umol / L in men and over 170 umol / L in women
• Patients with severe hepatic insufficiency (class C according to Child-Pugh).
• Patients receiving potassium-sparing diuretics, potassium supplements or strong inhibitors of CYP3A4 (eg. Itraconazole, ketoconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazodone)
• Simultaneous treatment of mild to moderate CYP3A4 inhibitors, eg. Amiodarone, diltiazem and verapamil
• diagnosing heart failure in the past
• In the past identified LV EF below 40%

Study & Design

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