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

Chronic Stable Angina Pectoris Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02315976
• Other study ID #: APPN 01-01-13
• Status: Completed
• Phase: Phase 4
• First received: November 29, 2014
• Last updated: October 24, 2017
• Start date: April 2014
• Est. completion date: December 2015

Study information

• Verified date: October 2017
• Source: Fundação Educacional Serra dos Órgãos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Chronic Stable Angina Pectoris

Intervention

Drug:
• Propatyl Nitrate
Propatyl nitrate 10mg administered orally, three times daily

Locations

Country	Name	City	State
Brazil	UNIFESO	Teresópolis	RJ

Sponsors (1)

Lead Sponsor	Collaborator
Fundação Educacional Serra dos Órgãos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of angina episodes	Number of angina episodes per patient during the 30 day treatment period	30-day treatment period
Secondary	Pain intensity	Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale)	30-day treatment period
Secondary	Episode duration	Number of angina episodes lasting two or more minutes	30-day treatment period
Secondary	Adverse Event - occurence	Number of patients presenting adverse events	30-day treatment period
Secondary	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
Secondary	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