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

Primary Purpose

Chronic Stable Angina Pectoris

Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Propatyl Nitrate
Sponsored by
Fundação Educacional Serra dos Órgãos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Stable Angina Pectoris focused on measuring chronic stable angina pectoris, propatyl nitrate, Seattle Angina Questionnaire

Eligibility Criteria

50 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNIFESO

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Propatyl nitrate

Arm Description

Patients treated with propatyl nitrate 10mg thrice daily

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain intensity
Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale)
Episode duration
Number of angina episodes lasting two or more minutes
Adverse Event - occurence
Number of patients presenting adverse events
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.
Seattle Angina Questionnaire (SAQ) Score increase >30%
Percentage of patients with Seattle Angina Questionnaire score improvement greater than or equal to 30%

Full Information

First Posted
November 29, 2014
Last Updated
October 24, 2017
Sponsor
Fundação Educacional Serra dos Órgãos
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1. Study Identification

Unique Protocol Identification Number
NCT02315976
Brief Title
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

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundação Educacional Serra dos Órgãos

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Stable Angina Pectoris
Keywords
chronic stable angina pectoris, propatyl nitrate, Seattle Angina Questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propatyl nitrate
Arm Type
Experimental
Arm Description
Patients treated with propatyl nitrate 10mg thrice daily
Intervention Type
Drug
Intervention Name(s)
Propatyl Nitrate
Intervention Description
Propatyl nitrate 10mg administered orally, three times daily
Primary Outcome Measure Information:
Title
Number of angina episodes
Description
Number of angina episodes per patient during the 30 day treatment period
Time Frame
30-day treatment period
Secondary Outcome Measure Information:
Title
Pain intensity
Description
Percentage of patients with moderate (50-69mm) to severe (>70mm) pain (100mm visual analog pain scale)
Time Frame
30-day treatment period
Title
Episode duration
Description
Number of angina episodes lasting two or more minutes
Time Frame
30-day treatment period
Title
Adverse Event - occurence
Description
Number of patients presenting adverse events
Time Frame
30-day treatment period
Title
Seattle Angina Questionnaire (SAQ) scales score improvements
Description
Improvement greater than or equal to 30% in SAQ scales scores of physical limitation, anginal stability, treatment satisfaction, and quality of life.
Time Frame
30-day treatment period
Title
Seattle Angina Questionnaire (SAQ) Score increase >30%
Description
Percentage of patients with Seattle Angina Questionnaire score improvement greater than or equal to 30%
Time Frame
30-day treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
UNIFESO
City
Teresópolis
State/Province
RJ
ZIP/Postal Code
25964-004
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

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