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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Stable Angina Pectoris
• Intervention / Treatment: Drug: Propatyl Nitrate

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Phase 4

Contacts and Locations

Study Locations

• Brazil
  • RJ
    • Teresópolis, RJ, Brazil, 25964-004
      • UNIFESO

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Propatyl nitrate; Patients treated with propatyl nitrate 10mg thrice daily	Drug: Propatyl Nitrate; Propatyl nitrate 10mg administered orally, three times daily

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundação Educacional Serra dos Órgãos

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 29, 2014
• First Submitted That Met QC Criteria: December 9, 2014
• First Posted (Estimate): December 12, 2014

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: chronic stable angina pectoris; propatyl nitrate; Seattle Angina Questionnaire
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Chest Pain; Angina Pectoris; Angina, Stable
• Other Study ID Numbers: APPN 01-01-13