An object of the present invention is to find a novel pharmaceutical drug combination that does not promote the risk of bleeding as adverse reaction and is useful in the prevention and/or treatment of thrombus and/or embolism. The present invention provides a pharmaceutical composition comprising N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide represented by the formula (I):or a pharmacologically acceptable salt thereof, or a solvate thereof, and clopidogrel or a pharmacologically acceptable salt thereof, or a solvate thereof. The present invention also provides a kit comprising: a pharmaceutical composition comprising N1-(5-chloropyridin-2-yl)-N2-((1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-{[(5-methyl-4,5,6,7-tetrahydrothiazolo[5,4-c]pyridin-2-yl)carbonyl]amino}cyclohexyl)ethanediamide represented by the formula (I) or a pharmacologically acceptable salt thereof, or a solvate thereof and a pharmaceutical composition comprising clopidogrel or a pharmacologically acceptable salt thereof, or a solvate thereof which may be packaged separately.本發明之目標係找出一種新穎之藥物組合,該組合不會增加出血之不良反應的風險,且可用於預防及/或治療血栓及/或栓塞。本發明提供一種醫藥組成物,其包含如式(I)表示之N1-(5-氯吡啶-2-基)-N2-((1S,2R,4S)-4-[(二甲基胺基)羰基]-2-{[(5-甲基-4,5,6,7-四氫噻唑并[5,4-c]吡啶-2-基)羰基]胺基}環己基)乙二醯胺:或其藥學上可接受之鹽或其溶劑合物,及氯吡格雷或其藥學上可接受之鹽或其溶劑合物。本發明亦提供一種套組,該套組包含:醫藥組成物,其包含如式(I)表示之N1-(5-氯吡啶-2-基)-N2-((1S,2R,4S)-4-[(二甲基胺基)羰基]-2-{[(5-甲基-4,5,6,7-四氫噻唑并[5,4-c]吡啶-2-基)羰基]胺基}環己基)乙二醯胺或其藥學上可接受之鹽或其溶劑合物;及一醫藥組成物,其包含氯吡格雷或其藥學上可接受之鹽或其溶劑合物;該等醫藥組成物可被分開包裝。
