Clinical trial NCT02315976: Acute Episodes in Chronic Stable Angina: Assessment of the Use of the Coronary Vasodilator Propatyl Nitrate.
Official title: Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Stable Angina Pectoris
Keywords: chronic stable angina pectoris
propatyl nitrate
Seattle Angina Questionnaire
Lead sponsor: Fundação Educacional Serra dos Órgãos
Sponsor class: OTHER
First posted: 2014-12-12
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of angina episodes
timeFrame: 30-day treatment period
Secondary outcomes:
measure: Pain intensity
timeFrame: 30-day treatment period
measure: Episode duration
timeFrame: 30-day treatment period
measure: Adverse Event - occurence
timeFrame: 30-day treatment period
measure: Seattle Angina Questionnaire (SAQ) scales score improvements
timeFrame: 30-day treatment period
measure: Seattle Angina Questionnaire (SAQ) Score increase >30%
timeFrame: 30-day treatment period
Other outcomes:
Locations:
city: Teresópolis
country: Brazil
facility: UNIFESO
state: RJ
Study officials:
References: