Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.
This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Comparative Study to Assess the Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment naïve Patients of Chronic Stable Angina.|
- SPECT Tc99m- Tetrofosmin (MYOVIEW) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
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.
- Exercise ECG Testing - Bruce protocol [ Time Frame: 4weeks ] [ Designated as safety issue: No ]
Secondary outcome measures 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
- Duration of exercise before the onset of angina or ST-segment depression (min)
- Max. work load (Mets)
- Max. ST depression (mm)
- HR at max. ST depression (beats/min)
- Syst. BP at max ST dep. (mm/Hg)
other measures are:
- Decrease in the frequency of anginal attacks
- Use of rescue medicines
- Adverse events reported
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||January 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Nicorandil test arm
Nicorandil is given with atenolol therapy.
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
Other Name: Nicorandil/ Nicoril
Active Comparator: Atenolol control arm
Atenolol 50 mg OD is given.
Patients in the control arm would be advised atenolol 50 mg od
Other Name: Atenolol/Atenorm
Show Detailed Description
|Contact: Tariq Ashraf, MBBS,FCPS,FACC,FSCAIfirstname.lastname@example.org|
|Contact: Hamid Tirmizey, MBBS,BSC,DIP.CARD.||email@example.com|
|National Institute of Cardiovascular Diseases||Recruiting|
|Karachi, Sind, Pakistan, 75850|
|Contact: Tariq Ashraf, MBBS, FCPS, FACC, FSCAI 092-03222999914 firstname.lastname@example.org|
|Contact: Hamid Tirmizey, MBBS, BSC, DIP. CARD 092-03212215383 email@example.com|
|Principal Investigator: Tariq Ashraf, MBBS, FCPS, FACC, FSCAI|
|Principal Investigator:||Tariq Ashraf, MBBS,FCPS,FACC,FSCAI||National Institute of Cardiovascular Diseases|