Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.
NCT ID: NCT01397994
Last Updated: 2011-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2011-09-30
2012-01-31
Brief Summary
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Detailed Description
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The effects of nitrates, potassium channel activators, calcium-channel blockers, and beta-blockers on myocardial perfusion imaging are likely attributable to changes in myocardial blood flow and myocardial oxygen supply-demand ratio. The major anti-ischemic effect of BBs is a reduction in myocardial oxygen consumption both at rest and during stress. Beta-blockers decrease myocardial oxygen demand through a reduction in heart rate, blood pressure, and myocardial contractility. They also prolong diastole, therefore increasing coronary perfusion time. The effect of chronic atenolol use on dipyridamole SPECT MPI was assessed in a randomized, double-blind, crossover study that showed no difference in the perfusion defect size and severity between placebo and atenolol for the group as a whole, although one-third of patients had larger defects on atenolol than placebo. Bridges et al., 1992 (56)
Nicorandil, a potassium channel activator, when given for 3 weeks exhibited significant improvement in myocardial perfusion in both MI and angina patients, on exercise thallium scan. Yamazaki et al., 1993 (69).
Atenolol as shown in the cross over study does not affect myocardial perfusion significantly and hence combination therapy with nicorandil will help us to determine a significant benefit of nicorandil on MP. Results will be analyzed from base line in the same arm and the difference will be further compared with control arm.
Guidelines suggest beta blockers as first line of therapy. To assess the anti ischemic effects of nicorandil, combination therapy with atenolol will be compared with atenolol alone. Since atenolol effect on MP is insignificant an added advantage of nicorandil can be evaluated in comparative study.
Primary objective is to assess the anti ischemic effect of nicorandil.
The primary endpoint is to compare the anti ischemic effect over 4 weeks period.
Changes in perfusion will be evaluated in each arm at week 4 and comparison between the two study arms will be made to document the anti ischemic effects of nicorandil.
Primary efficacy variables of the study are the difference of the following endpoints from the baseline at week 4 and comparison between control and study arm using Ex- SPECT MPI.
Secondary efficacy variables of the study are the difference of the following endpoints from the baseline and comparison between control and study arm using ETT Bruce Protocol at week 4.
Secondary objectives of the study are to evaluate the anti anginal effect and safety of Nicorandil.
This is an open label, randomized controlled pilot study. Sponsor of this study is Ferozsons Labs. Ltd. All participating patients must sign a written informed consent form.
Eligible patients with proven CAD having at least one reversible or partially reversible myocardial perfusion defects on MPI SPECT - Tc-99m and functional class I \& II of CSA, and laboratory values within predefined safety limits will be recruited.
Chief exclusion criteria include presence of only fixed perfusion defects, CSA functional class III and IV and prior revascularization.
A total of 40 patients will be enrolled in the study, 20 patients in each arm). Patients will be randomized in a 1:1 fashion to receive beta blocker in combination with nicorandil (experiment arm) or beta blocker (control arm) for four weeks until unacceptable toxicity, withdrawal of consent, whichever comes first.
Nicorandil dose will be titrated from 10mg bd for 7days to 20mg bd for next 3 weeks. Concurrent therapy for angina attacks will be allowed to be used with study medication.
All patients will have treadmill exercise using Bruce protocol. At peak exercise, 10-15 mCi of technetium - 99m tetrofosmin is injected and patient will exercise an additional 1 to 2 minutes.. Stress SPECT images will be acquired beginning 15 to 45 minutes after the completion of treadmill stress. At rest 30 mCi of technetium-99m tetrofosmin will be injected and SPECT images will be acquired using same protocol.
Study monitoring at the centre will be provided by the sponsor
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nicorandil test arm
Nicorandil is given with atenolol therapy.
Nicorandil
Patients would be advised 10mg bd nicorandil for the first seven days. Drug will be titrated to 20 mg bd after one week, atenolol 50 mg will be given along with nicorandil from day 1
Atenolol control arm
Atenolol 50 mg OD is given.
Atenolol
Patients in the control arm would be advised atenolol 50 mg od
Interventions
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Nicorandil
Patients would be advised 10mg bd nicorandil for the first seven days. Drug will be titrated to 20 mg bd after one week, atenolol 50 mg will be given along with nicorandil from day 1
Atenolol
Patients in the control arm would be advised atenolol 50 mg od
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female
3. Age 25 to 65 years
4. Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards.
5. Patient must be able to give voluntary written informed consent.
Exclusion Criteria
2. Valvular heart disease and cardiomyopathy
3. Myocardial infarction in \< 6 months
4. Unstable angina
5. Congestive cardiac failure
6. Severe anemia (Hb 7G/dl)
7. Cardiac arrhythmias or II or III degree AV block
8. Significant liver or renal dysfunction
9. IDDM (Type-1 diabetes mellitus)
10. Systolic blood pressure \< 100 mm Hg
11. Pregnant and nursing women
12. Known hypersensitivity to nicorandil
13. On calcium channel blockers
14. Patients not eligible for Tc 99m SPECT
15. Patients in whom beta blockers are contraindicated
16. Geographical inaccessibility for treatment or follow-up evaluations
25 Years
65 Years
ALL
No
Sponsors
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Ferozsons Laboratories Ltd.
INDUSTRY
Responsible Party
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Dr. Tariq Ashraf
Assistant Professor Of cardiology, National Institute of Cardiovascular Diseases
Principal Investigators
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Tariq Ashraf, MBBS,FCPS,FACC,FSCAI
Role: PRINCIPAL_INVESTIGATOR
National Institute of Cardiovascular Diseases
Locations
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National Institute of Cardiovascular Diseases
Karachi, Sindh, Pakistan
Countries
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Central Contacts
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Facility Contacts
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Tariq Ashraf, MBBS, FCPS, FACC, FSCAI
Role: primary
Hamid Tirmizey, MBBS, BSC, DIP. CARD
Role: backup
Other Identifiers
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FZS NICORIL STUDY 01
Identifier Type: -
Identifier Source: org_study_id