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

This study is currently recruiting participants.
Verified December 2011 by Ferozsons Laboratories Ltd.
Sponsor:
Information provided by (Responsible Party):
Dr. Tariq Ashraf, Ferozsons Laboratories Ltd.
ClinicalTrials.gov Identifier:
NCT01397994
First received: July 18, 2011
Last updated: December 7, 2011
Last verified: December 2011
History of Changes
  Purpose

This study is to determine the anti-anginal and anti-ischemic effect of k-channel opener, nicorandil in patients of chronic stable angina.


Condition Intervention Phase
Chronic Stable Angina
 Drug: Nicorandil
Drug: Atenolol
 Phase 4

Study Type: Interventional
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.

Resource links provided by NLM:

MedlinePlus related topics: Angina
Drug Information available for: Atenolol
U.S. FDA Resources

Further study details as provided by Ferozsons Laboratories Ltd.:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 40
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)
Arms Assigned Interventions
Active Comparator: Nicorandil test arm
Nicorandil is given with atenolol therapy.
 Drug: 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
Other Name: Nicorandil/ Nicoril
Active Comparator: Atenolol control arm
Atenolol 50 mg OD is given.
 Drug: Atenolol
Patients in the control arm would be advised atenolol 50 mg od
Other Name: Atenolol/Atenorm

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients of chronic stable angina with abnormal Exercise Myocardial Perfusion Spect Scan with reversible and partially reversible ischemic changes.
  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:

  1. Hypertension of > 170/100 mm of Hg
  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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01397994

Contacts
Contact: Tariq Ashraf, MBBS,FCPS,FACC,FSCAI 092-03222999914 tariqashraf2009@hotmail.com
Contact: Hamid Tirmizey, MBBS,BSC,DIP.CARD. 092-03212215383 alafzal1@yahoo.com

Locations
Pakistan
National Institute of Cardiovascular Diseases Recruiting
Karachi, Sind, Pakistan, 75850
Contact: Tariq Ashraf, MBBS, FCPS, FACC, FSCAI     092-03222999914     tariqashraf2009@hotmail.com    
Contact: Hamid Tirmizey, MBBS, BSC, DIP. CARD     092-03212215383     alafzal1@yahoo.com    
Principal Investigator: Tariq Ashraf, MBBS, FCPS, FACC, FSCAI            
Sponsors and Collaborators
Ferozsons Laboratories Ltd.
Investigators
Principal Investigator: Tariq Ashraf, MBBS,FCPS,FACC,FSCAI National Institute of Cardiovascular Diseases
  More Information

No publications provided

Responsible Party: Dr. Tariq Ashraf, Assistant Professor Of cardiology, National Institute of Cardiovascular Diseases, Ferozsons Laboratories Ltd.
ClinicalTrials.gov Identifier: NCT01397994     History of Changes
Other Study ID Numbers: FZS NICORIL STUDY 01
Study First Received: July 18, 2011
Last Updated: December 7, 2011
Health Authority: Pakistan: Research Ethics Committee

Keywords provided by Ferozsons Laboratories Ltd.:
Nicorandil therapy in patients of chronic stable angina

Additional relevant MeSH terms:
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Atenolol
Nicorandil
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
 Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 22, 2013