Clinical Trial: Study to Assess Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment of Chronic Stable Angina.

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

Official Title: A Comparative Study to Assess the Efficacy of Nicorandil+Atenolol vs Atenolol in Treatment naïve Patients of Chronic Stable Angina.

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.

Detailed Summary:

Stress myocardial perfusion imaging (MPI) is widely used for the diagnosis and risk assessment of patients with known or suspected coronary artery disease (CAD). Also, MPI lends itself to monitoring the effects of therapeutic interventions such as anti-ischemic medications, gene therapy, and various percutaneous and surgical revascularization modalities.

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.

Sponsor: Ferozsons Laboratories Ltd.

Current Primary Outcome: SPECT Tc99m- Tetrofosmin (MYOVIEW) [ Time Frame: 4 weeks ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome: Exercise ECG Testing - Bruce protocol [ Time Frame: 4weeks ]

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


Original Secondary Outcome: Same as current

Information By: Ferozsons Laboratories Ltd.

Dates:
Date Received: July 18, 2011
Date Started: September 2011
Date Completion: January 2012
Last Updated: December 7, 2011
Last Verified: December 2011