Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.
A Comparative Study to Assess the Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment naïve Patients of Chronic Stable Angina.
1 other identifier
interventional
40
1 country
1
Brief Summary
This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Sep 2011
Shorter than P25 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
July 18, 2011
CompletedFirst Posted
Study publicly available on registry
July 20, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedDecember 8, 2011
December 1, 2011
4 months
July 18, 2011
December 7, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SPECT Tc99m- Tetrofosmin (MYOVIEW)
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 nicorandilusing Ex- SPECT MPI. * Improvement in SDS after 4 weeks of treatment (Summed Stress Score SSS, Summed Rest Score SRS, Summed Difference Score SDS) * Difference in number of reversible, partially reversible defects. * Improvement in the extent and severity of ischemic lesions.
4 weeks
Secondary Outcomes (1)
Exercise ECG Testing - Bruce protocol
4weeks
Study Arms (2)
Nicorandil test arm
ACTIVE COMPARATORNicorandil is given with atenolol therapy.
Atenolol control arm
ACTIVE COMPARATORAtenolol 50 mg OD is given.
Interventions
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
Patients in the control arm would be advised atenolol 50 mg od
Eligibility Criteria
You may qualify if:
- Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.
- Male and female
- Age 25 to 65 years
- Patient must understand and be willing, able and likely to comply with all study procedures and restrictions and comprehends the diary cards.
- Patient must be able to give voluntary written informed consent.
You may not qualify if:
- Hypertension of \> 170/100 mm of Hg
- Valvular heart disease and cardiomyopathy
- Myocardial infarction in \< 6 months
- Unstable angina
- Congestive cardiac failure
- Severe anemia (Hb 7G/dl)
- Cardiac arrhythmias or II or III degree AV block
- Significant liver or renal dysfunction
- IDDM (Type-1 diabetes mellitus)
- Systolic blood pressure \< 100 mm Hg
- Pregnant and nursing women
- Known hypersensitivity to nicorandil
- On calcium channel blockers
- Patients not eligible for Tc 99m SPECT
- Patients in whom beta blockers are contraindicated
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institute of Cardiovascular Diseases
Karachi, Sindh, 75850, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tariq Ashraf, MBBS,FCPS,FACC,FSCAI
National Institute of Cardiovascular Diseases
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor Of cardiology, National Institute of Cardiovascular Diseases
Study Record Dates
First Submitted
July 18, 2011
First Posted
July 20, 2011
Study Start
September 1, 2011
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
December 8, 2011
Record last verified: 2011-12