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Trial record 9 of 116 for:    Atenolol

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01397994
Recruitment Status : Unknown
Verified December 2011 by Dr. Tariq Ashraf, Ferozsons Laboratories Ltd..
Recruitment status was:  Recruiting
First Posted : July 20, 2011
Last Update Posted : December 8, 2011
Information provided by (Responsible Party):
Dr. Tariq Ashraf, Ferozsons Laboratories Ltd.

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.

Condition or disease Intervention/treatment Phase
Chronic Stable Angina Drug: Nicorandil Drug: Atenolol Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : September 2011
Estimated Primary Completion Date : January 2012
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina
Drug Information available for: Atenolol

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01397994

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Contact: Tariq Ashraf, MBBS,FCPS,FACC,FSCAI 092-03222999914
Contact: Hamid Tirmizey, MBBS,BSC,DIP.CARD. 092-03212215383

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National Institute of Cardiovascular Diseases Recruiting
Karachi, Sind, Pakistan, 75850
Contact: Tariq Ashraf, MBBS, FCPS, FACC, FSCAI    092-03222999914   
Contact: Hamid Tirmizey, MBBS, BSC, DIP. CARD    092-03212215383   
Principal Investigator: Tariq Ashraf, MBBS, FCPS, FACC, FSCAI         
Sponsors and Collaborators
Ferozsons Laboratories Ltd.
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Principal Investigator: Tariq Ashraf, MBBS,FCPS,FACC,FSCAI National Institute of Cardiovascular Diseases

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Responsible Party: Dr. Tariq Ashraf, Assistant Professor Of cardiology, National Institute of Cardiovascular Diseases, Ferozsons Laboratories Ltd. Identifier: NCT01397994     History of Changes
Other Study ID Numbers: FZS NICORIL STUDY 01
First Posted: July 20, 2011    Key Record Dates
Last Update Posted: December 8, 2011
Last Verified: December 2011
Keywords provided by Dr. Tariq Ashraf, Ferozsons Laboratories Ltd.:
Nicorandil therapy in patients of chronic stable angina
Additional relevant MeSH terms:
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Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Anti-Arrhythmia Agents
Antihypertensive Agents
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
Growth Substances