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Completed

NCT Number: NCT02315976

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

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.

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Key information

Conditions

Chronic Stable Angina Pectoris

Age range

50 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UNIFESO

Teresópolis, Rio de Janeiro, 25964-004, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Propatyl Nitrate

Drug

Propatyl nitrate 10mg administered orally, three times daily

Primary outcomes

  1. Number of angina episodes

    Time frame: 30-day treatment period

    Number of angina episodes per patient during the 30 day treatment period

Secondary outcomes

  1. Pain intensity

    Time frame: 30-day treatment period

    Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale)

  2. Episode duration

    Time frame: 30-day treatment period

    Number of angina episodes lasting two or more minutes

  3. Adverse Event - occurence

    Time frame: 30-day treatment period

    Number of patients presenting adverse events

  4. Seattle Angina Questionnaire (SAQ) scales score improvements

    Time frame: 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.

  5. Seattle Angina Questionnaire (SAQ) Score increase >30%

    Time frame: 30-day treatment period

    Percentage of patients with Seattle Angina Questionnaire score improvement greater than or equal to 30%

Sponsors and collaborators

Lead sponsor

Fundação Educacional Serra dos Órgãos

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Dec 12, 2014
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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