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Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01769079
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : January 3, 2014
Information provided by (Responsible Party):
Hospital de Clinicas de Porto Alegre

Brief Summary:

Chronic treatment of stable angina with nitrates long and short action is extremely frequent. In clinical practice the most commonly observed is a combination of anti-anginal agents, usually including nitrates fixed in an attempt to improve the quality of life of patients, which is not always met with success.

Numerous questions and problems are seen with chronic use of oral nitrates. From a practical standpoint, some advocate the withdrawal of medication in stable patients, while many physicians still hesitate to withdraw the medication by the lack of definitive information about its consequences. In this sense there is a rationale for the attempted removal of nitrate fixed these patients, although evidence to support this action have not been adequately evaluated.

Condition or disease Intervention/treatment Phase
Stable Angina Myocardial Ischemia Quality of Life Drug: Nitrate Drug: Placebo Phase 4

Detailed Description:
The Ischemic Heart Disease remains in recent years as a major cause of mortality in most of the world, and also the disease that consumes more resources in health in industrialized countries. The use of fixed nitrate in patients with stable angina is quite common, but there is a scarcity of studies showing the need for this medication in this class pacientes.Este study aims to evaluate the consequences of the withdrawal of fixed nitrate in patients with stable angina class I and II, hemodynamically stable for the past six months, as the frequency and duration of episodes of angina, silent ischemia and functional capacity by exercise testing, 24-hour Holter and measurement of quality of life and adherence to therapy. For this purpose, a randomized blinded multicenter clinical trial was designed to placebo (intervention group) X nitrate (control group) in a follow-up period for 4 months. Both groups will receive three evaluations (baseline, 30 days and 120 days) during follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 95 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Withdrawal of Nitrate in Patients With Stable Angina - Multicenter Clinical Trial
Study Start Date : September 2009
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Isosorbide

Arm Intervention/treatment
Active Comparator: oral nitrate
In nitrate group will be provided the same prescribed dose for this drug. One group remains on nitrate use and other on placebo (same number of pills) use.
Drug: Nitrate
Two arms: placebo and nitrate
Other Name: Isosorbide

Placebo Comparator: Placebo
In the placebo group will be given the same dose and frequency prescribed nitrate.
Drug: Placebo

Primary Outcome Measures :
  1. Time of exercise on treadmill test [ Time Frame: 4 months ]
    Evaluate exercise tolerance, time to onset of ischemia and total duration of exercise by exercise testing in patients with stable angina in withdrawal nitrate fixed.

Secondary Outcome Measures :
  1. angina function class and time to ischemia on treadmill test [ Time Frame: 4 months ]
    Evaluate the occurrence of angina and/or worsening of functional class (CCS). Assess exercise tolerance and time to onset of ischemia (clinical and electrocardiographic parameters) and total exercise time, through the exercise test. Rate load silent ischemia through 24-hour Holter. Assess quality of life measured by questionnaire Short-Form 36 and Seattle and adherence to medication. Estimate the impact of the withdrawal of nitrate in the Unified Health System.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients of both sexes, aged 18 years or above, with coronary artery disease documented by angiography or noninvasive test (scintigraphy) with stable angina functional class I or II of the Canadian Cardiothoracic Society (CCS), clinically stable for at least six months, using two or more antianginal agents (betablockers or calcium channel antagonist), among them nitrate fixed.

Exclusion Criteria:

  • Patients with residence far from the research center and unable to appropriate follow-up. Patients with decompensated heart failure symptoms or class III or IV New York Heart Association (NYHA), poorly controlled hypertension (BP greater than 160/90 mmHg), patients unable to walk or perform stress test and ECG interpretable. Also excluded were patients in the exercise test pre-randomization present significant alterations.

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 identifier (NCT number): NCT01769079

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Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-903
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
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Principal Investigator: Carisi A Polanczyk, MD, ScD Federal University of Rio Grande do Sul

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Responsible Party: Hospital de Clinicas de Porto Alegre Identifier: NCT01769079     History of Changes
Other Study ID Numbers: GPPG 08-168
First Posted: January 16, 2013    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Angina Pectoris
Myocardial Ischemia
Angina, Stable
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Diuretics, Osmotic
Natriuretic Agents
Physiological Effects of Drugs