Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of angina episodes
研究概览
简要总结
This is an open, self-paired study of 200 patients with heart failure who have a diagnosis of chronic stable angina pectoris, who will be treated for 30 days with propatyl nitrate (10mg) . Treatment regimen is 3 sublingual tablets per day, at 8:00 AM, 2:00 PM, and 8:00 PM. The study will include three visits the patient to the study center: Pretreatment / Assessment 1, Assessment 2 after 15 days of treatment, and the Assessment 3 after 30 days of treatment. At each visit, data will be collected on the medical history, physical examination and vital signs, and evaluation of episodes of angina pectoris, as well as the laboratory evaluation of adverse events and the use of concomitant medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 68 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of chronic stable angina pectoris
- •Female subjects post-menopausal or not pregnant and using of contraceptives
- •Signature of Informed consent document
排除标准
- •Pregnant women or nursing patients , women of childbearing age
- •Hypersensitivity or intolerance to any component of the study drug
- •Angina pectoris Class IV, according to the Canadian Society of Cardiology
- •Clinical diagnosis of severe anemia , glaucoma, head trauma , increased intracranial pressure, cerebral hemorrhage, acute myocardial infarction, congestive heart failure, aortic valve disease
- •Recent infarction (within the last 3 months)
- •Recent history (within the last 6 months)of angioplasty
- •Use of these medicines within 7 days screening : sildenafil citrate and other inhibitors of phosphodiesterase-5 , adrenergic substances
- •Significant alteration of any laboratory test (> 20% above or below the normal range )
- •Gastric or intestinal ulcer or intestinal
- •Asthma or chronic rhinitis
- •Any other condition which in the opinion of the investigator, shall exclude the study of the patient.
研究组 & 干预措施
Propatyl nitrate
Patients treated with propatyl nitrate 10mg thrice daily
干预措施: Propatyl Nitrate (Drug)
结局指标
主要结局
Number of angina episodes
时间窗: 30-day treatment period
Number of angina episodes per patient during the 30 day treatment period
次要结局
- Adverse Event - occurence(30-day treatment period)
- Episode duration(30-day treatment period)
- Pain intensity(30-day treatment period)
- Seattle Angina Questionnaire (SAQ) scales score improvements(30-day treatment period)
- Seattle Angina Questionnaire (SAQ) Score increase >30%(30-day treatment period)
研究者
Carlos Pereira Nunes
Professor of Internal Medicine
Fundação Educacional Serra dos Órgãos