EUCTR2014-005407-24-CZ进行中（未招募）1 期
Effect of early administration of eplerenone in patients after acute myocardial infarction
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- IKEM
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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%
研究者
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