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Randomized Controlled Trial
Competency profile of locally manufactured clopidogrel Lowplat and foreign manufactured clopidogrel Plavix in patients of suspected ischemic heart disease (CLAP-IHD).
- Tariq Ashraf, Munir Ahmed, M Saeed Talpur, Asadullah Kundi, Azhar Masood A Faruqui, Abdul Hafeez Jaffery, and Aslam Fareed.
- National Institute of Cardiovascular Diseases, Karachi, Pakistan.
- J Pak Med Assoc. 2005 Oct 1; 55 (10): 443-8.
ObjectiveThe primary objective of this study was to test the hypothesis that the antiplatelet effects of loading dose of locally manufactured clopidogrel Lowplat referred as drug (B) 600 mg (8 tablets) given once is comparable to the antiplatelet effects of loading dose of foreign manufactured clopidogrel Plavix referred as drug (A) 600 mg (8 tablets) given once in patients with suspected ischemic heart disease.MethodsThis was a double blind, randomized, cross over, study, to compare the safety and efficacy of study drug (B) versus (A) in adult subjects suffering from suspected ischemic heart disease presented at National Institute of Cardiovascular Disease (NICVD), Karachi.ResultsMean platelet aggregation inhibition by drug (B) was 60.7% (p<0.001), while with drug (A) it was 57.8% (p<0.001), using 20 micromol/L ADP, which is statistically significant and comparable. Clopidogrel 600 mg as loading dose was well tolerated.ConclusionBoth drugs were equally effective in reducing the platelet aggregation. CLAP-IHD confirmed that drug (B) and (A) are equally effective and comparable antithrombotics in Pakistani population. The cost benefit of drug (B) should be made beneficial to the patients.
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