Competency profile of locally manufactured clopidogrel lowplat and foreign manufactured clopidogrel plavix in patients of suspected ischemic heart disease [CLAP-IHD]

ABSTRACT

The 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. This 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. Mean 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 micro mol/L ADP, which is statistically significant and comparable. Clopidogrel 600 mg as loading dose was well tolerated. Both 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