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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:
Sponsor: Fundação Educacional Serra dos Órgãos

Current Primary Outcome: Number of angina episodes [ Time Frame: 30-day treatment period ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Pain intensity [ Time Frame: 30-day treatment period ]
    Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale)
  • Episode duration [ Time Frame: 30-day treatment period ]
    Number of angina episodes lasting two or more minutes
  • Adverse Event - occurence [ Time Frame: 30-day treatment period ]
    Number of patients presenting adverse events
  • 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.
  • 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%


Original Secondary Outcome: Same as current

Information By: Fundação Educacional Serra dos Órgãos

Dates:
Date Received: November 29, 2014
Date Started: April 2014
Date Completion: December 2015
Last Updated: December 4, 2015
Last Verified: December 2015