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

Chronic Stable Angina research study

What is the primary objective of this study?

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

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Chronic Stable Angina

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:NicorandilPatients 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

Drug:AtenololPatients in the control arm would be advised atenolol 50 mg od

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Nicorandil test armNicorandil is given with atenolol therapy.

Atenolol control armAtenolol 50 mg OD is given.

Study Status

Unknown status

Start Date: September 2011

Completed Date: January 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: SPECT Tc99m- Tetrofosmin (MYOVIEW)

Secondary Outcome: Exercise ECG Testing - Bruce protocol

Study sponsors, principal investigator, and references

Principal Investigator: Tariq Ashraf, MBBS,FCPS,FACC,FSCAI

Lead Sponsor: Ferozsons Laboratories Ltd.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01397994

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