Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.

Study Overview
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Brief Summary
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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.

Official Title
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Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.

Conditions
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Chronic Stable Angina Pectoris

Intervention / Treatment
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* Drug: Propatyl Nitrate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronic stable angina pectoris Female subjects post-menopausal or not pregnant and using of contraceptives Signature of Informed consent document Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Propatyl nitrate<br>Patients treated with propatyl nitrate 10mg thrice daily | Drug: Propatyl Nitrate<br>* Propatyl nitrate 10mg administered orally, three times daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of angina episodes | Number of angina episodes per patient during the 30 day treatment period | 30-day treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale) | 30-day treatment period | 
| Episode duration | Number of angina episodes lasting two or more minutes | 30-day treatment period | 
| Adverse Event - occurence | Number of patients presenting adverse events | 30-day treatment period | 
| Seattle Angina Questionnaire (SAQ) scales score improvements | Improvement greater than or equal to 30% in SAQ scales scores of physical limitation, anginal stability, treatment satisfaction, and quality of life. | 30-day treatment period | 
| Seattle Angina Questionnaire (SAQ) Score increase >30% | Percentage of patients with Seattle Angina Questionnaire score improvement greater than or equal to 30% | 30-day treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic stable angina pectoris, propatyl nitrate, Seattle Angina Questionnaire