Clinical Impact of the Withdrawal of Nitrate in Patients With Stable Angina
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|ClinicalTrials.gov Identifier: NCT01769079|
Recruitment Status : Completed
First Posted : January 16, 2013
Last Update Posted : January 3, 2014
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||95 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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.
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.
- 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.
- 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.
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): NCT01769079
|Hospital de Clínicas de Porto Alegre|
|Porto Alegre, RS, Brazil, 90035-903|
|Principal Investigator:||Carisi A Polanczyk, MD, ScD||Federal University of Rio Grande do Sul|