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

Phase 4

Completed

• Conditions: Chronic Stable Angina Pectoris
• Interventions: Drug: Propatyl Nitrate

• Registration Number: NCT02315976
• Lead Sponsor: Fundação Educacional Serra dos Órgãos

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-11-29
• Primary Completion: 2014-12
• Study First Submitted QC: 2014-12-09
• Study First Posted: 2014-12-12
• Study Completion: 2015-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propatyl nitrate	Propatyl Nitrate	Patients treated with propatyl nitrate 10mg thrice daily

Primary Outcome Measures

Name	Time	Method
Number of angina episodes	30-day treatment period	Number of angina episodes per patient during the 30 day treatment period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UNIFESO; 🇧🇷 Teresópolis, RJ, Brazil