NCT01769079

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2009

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 16, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

4.3 years

First QC Date

October 31, 2012

Last Update Submit

January 2, 2014

Conditions

Stable AnginaMyocardial IschemiaQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Time of exercise on treadmill test

    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.

    4 months

Secondary Outcomes (1)

  • angina function class and time to ischemia on treadmill test

    4 months

Study Arms (2)

oral nitrate

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

In the placebo group will be given the same dose and frequency prescribed nitrate.

Drug: Placebo

Interventions

NitrateDRUG

Two arms: placebo and nitrate

Also known as: Isosorbide
oral nitrate
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

MeSH Terms

Conditions

Angina, StableMyocardial Ischemia

Interventions

NitratesIsosorbide

Condition Hierarchy (Ancestors)

Angina PectorisHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsNitric AcidNitrogen CompoundsOrganic ChemicalsSorbitolSugar AlcoholsAlcoholsCarbohydrates

Study Officials

  • Carisi A Polanczyk, MD, ScD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

January 16, 2013

Study Start

September 1, 2009

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

BR(1)