EUCTR2015-003149-24-IT进行中（未招募）1 期
Ranolazine in patients with post systolic thickening due to stable effort angina: a phase II, randomized, open-label, standard therapy controlled, parallel group study assessing the effects on left ventricular function, exercise capacity and symptomatic status - Ranolazine - AOUPi/001
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 28
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
- •Male and female gender (females of childbearing potential must be using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner);
- •Females of childbearing potential or within two years from the menopause must have a negative urine pregnancy test;
- •Patients which diagnosis of stable effort chronic angina based on clinical symptoms (angina; ischemic equivalents) or ischemia tests (stress ECG/stress-exercise echocardiography/Miocardial perfusion scintigraphy) independently from baseline antianginal therapy.
- •Patients aged = 18 years;
- •Patients with normal LV ejection fraction (EF) without LV wall motion abnormalities detected by standard echocardiography or if abnormalities are present, the post systolic thickening must be present in a different, non-contiguous segment;
- •Patients with post systolic thickening independently from baseline antianginal therapy, defined as the presence of SI = 50%, 5 min. during and/or after the supine bicycle speckle tracking echo stress (speckle tracking) test performed by using the standard Bruce protocol;
- •Presence of sinus rhythm;
- •Written informed consent prior to enrolment into the study.
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Females of childbearing potential not using adequate contraceptive precautions;
- •Presence of unstable angina, left main trunk disease, previous myocardial infarction, previous cardiac surgery, artificial pacemaker, non-sinus rhythm, significant valvular heart disease;
- •Presence of congestive heart failure;
- •Presence of Chronic Obstructive Airways Disease;
- •Concomitant administration of potent CYP3A4 inhibitors (e.g. itraconazole, ketoconazole, voriconazol, posaconazol, HIV protease inhibitors, clarithromycin, telithromycin, nefazodone). Grapefruit juice is also a potent CYP3A4 inhibitor.
- •Concomitant administration of Class Ia (e.g. quinidine) or Class III (e.g. dofetilide, sotalol) antiarrhythmics other than amiodarone.
- •Any clinically relevant haematological or biochemical abnormality on routine screening, according to Investigator’s judgment;
- •Severe concurrent pathology, including terminal illness (cancer, AIDS, etc.);
- •Severe renal impairment defined as GFR < 29 mL/min; creatinine level > 2.5 mg/dL; BUN >60 mg/dL;
- •Moderate or severe hepatic impairment or hepatic insufficiency defined as SGOT or SGPT > 2 times greater than normal upper limit or total serum bilirubin > 1.5 times greater than normal upper limit;
- •Dementia, psychosis, alcoholism (>350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances;
- •Females who are pregnant or lactating;
- •Conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the patient should not participate for safety reasons;
- •Risk of low patient cooperation;
- •Inability or unwillingness to issue the informed consent;
- •Inability to perform an exercise stress test.
研究者
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