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

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ClinicalTrials.gov Identifier: NCT02315976
Recruitment Status : Completed
First Posted : December 12, 2014
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos

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.

Condition or disease Intervention/treatment Phase
Chronic Stable Angina Pectoris Drug: Propatyl Nitrate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Avaliação de episódios Agudos na Angina Pectoris crônica estável: Abordagem clínico-laboratorial do Uso do Vasodilatador Coronariano Propatilnitrato.
Study Start Date : April 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

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




Primary Outcome Measures :
  1. Number of angina episodes [ Time Frame: 30-day treatment period ]
    Number of angina episodes per patient during the 30 day treatment period


Secondary Outcome Measures :
  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%



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Ages Eligible for Study:   50 Years to 68 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315976


Locations
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Brazil
UNIFESO
Teresópolis, RJ, Brazil, 25964-004
Sponsors and Collaborators
Fundação Educacional Serra dos Órgãos

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Responsible Party: Carlos Pereira Nunes, Professor of Internal Medicine, Fundação Educacional Serra dos Órgãos
ClinicalTrials.gov Identifier: NCT02315976     History of Changes
Other Study ID Numbers: APPN 01-01-13
First Posted: December 12, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017

Keywords provided by Carlos Pereira Nunes, Fundação Educacional Serra dos Órgãos:
chronic stable angina pectoris
propatyl nitrate
Seattle Angina Questionnaire

Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms