The METHRO II study was a double-blind, dose-finding study and a comparator agent was used. The primary purpose of the study was to determine the dose-response relationship with regard to efficacy for the oral direct thrombin inhibitor, H 376/95, preceded by subcutaneous administration of melagatran. The METHRO II study was also designed to compare the efficacy of the H 376/95 regimen with conventional prophylaxis using the injectable low molecular weight heparin agent, dalteparin.
Patients were randomised to one of four melagatran/H 376/95 regimens or dalteparin for 8-11 days. The regimens were: 1mg, 1.5mg, 2.25mg or 3mg melagatran subcutaneously twice daily followed by 8mg, 12mg, 18mg or 24mg oral H 376/95 twice daily respectively or dalteparin 5000 IU once daily subcutaneously. A diagnostic procedure, phlebography, was carried out on the final day of treatment. Patient follow-up was 4-6 weeks post-operatively. Two-thirds of the patients underwent hip replacement and one-third knee replacement surgery. The age range was 18-85 years.
There was a clear relationship between the dose regimen of H 376/95 and the occurrence of
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