Study Number	Completed Clinical Trial Report Summaries
SH-TPA-0002	Tolerability and Safety of the Oral Thrombin Inhibitor H 376/95 (ximelagatran), Compared to Warfarin, as Stroke Prophylaxis in Patients with Atrial Fibrillation. A Dose-Guiding, Feasibility Multicentre Study (SPORTIF II)
SH-TPA-0003	Efficacy and Safety Study of the Oral Direct Thrombin Inhibitor Ximelagatran Compared with Dose-Adjusted Warfarin in the Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation (SPORTIF III)
SH-TPA-0004(5 year iterim analysis)	Long-Term Treatment with the Oral Direct Thrombin Inhibitor H 376/95, Compared to Warfarin, as Stroke Prophylaxis in Patients with Atrial Fibrillation. An Open 10-Year Follow-up Study: 5-year interim analysis report (Visits 1-26)SPORTIF IV was an extension of SPORTIF II (SH TPA 0002). Information on both studies is combined in this report.
SH-TPA-0004(Final Report)	Long-Term Treatment with the Oral Direct Thrombin Inhibitor H 376/95, Compared to Warfarin, as Stroke Prophylaxis in Patients with Atrial Fibrillation. An Open 10-Year Follow-up Study. Final report at 7 years (Supplement to 5-year interim analysis report) SPORTIF IV was an extension of SPORTIF II (SH TPA 0002). Information on both studies is combined in this report.
SH-TPA-0005	Efficacy and Safety Study of the Oral Direct Thrombin Inhibitor Ximelagatran (H 376/95) Compared with Dose-Adjusted Warfarin (Coumadin®) in the Prevention of Stroke and Systemic Embolic Events in Patients with Atrial Fibrillation (SPORTIF V)
SH-TPC-0001	Efficacy and Safety of H 376/95 (ximelagatran), in Combination with Aspirin, in Patients with a Recent Acute Coronary Syndrome with Elevated Biochemical Markers of Myocardial Damage. A Multicentre, Double-Blind, Controlled, Dose-Guiding Study (ESTEEM)
SH-TPO-0002	Efficacy and safety of oral treatment twice daily with H 376/95 (ximelagatran), preceded by subcutaneous injections with melagatran, compared with dalteparin subcutaneous once daily, as prophylaxis against thromboembolic complications after total hip or knee replacement (METHRO II)
SH-TPO-0003	Efficacy and safety of melagatran and H 376/95 (ximelagatran) compared with enoxaparin as prophylaxis against venous thromboembolism after total hip- or knee replacement (METHRO III)
SH-TPO-0004	Dose-finding, safety, and pharmacokinetics of H 376/95 (ximelagatran) given postoperatively as prophylaxis for thromboembolic complications after total knee replacement.
SH-TPO-0005	A randomized, double-blind, comparative study of ximelagatran (H 376/95) and enoxaparin for the prevention of venous thromboembolism following total hip arthroplasty. (PLATINUM Hip)
SH-TPO-0006	A randomized, double-blind, comparative study of H 376/95 (ximelagatran) and warfarin (COUMADIN®) for the prevention of venous thromboembolism following total knee arthroplasty. (PLATINUM Knee)
SH-TPO-0007	A randomized, double-blind, double-dummy, parallel-group, phase III, multicentre study comparing the efficacy and safety of melagatran and ximelagatran with enoxaparin after total hip or knee replacement (EXPRESS)
SH-TPO-0010	EXULT KNEE: Optimization of Dose (Study A) and Confirmation of Safety and Efficacy (Study B) of H 376/95 (Oral Direct Thrombin Inhibitor, ximelagatran) Compared to Warfarin (COUMADIN®) for the Prevention of Venous Thromboembolism Following Total Knee Arthroplasty This Clinical Study Report describes the methods and results for the refinement of dose (EXULT 290A). The confirmation of safety and efficacy (EXULT 290B) methods and results are described in a separate Clinical Study Report
SH-TPO-0012	EXULT KNEE: Optimization of Dose (Study A) and Confirmation of Safety and Efficacy (Study B) of H 376/95 (Oral Direct Thrombin Inhibitor ximelagatran) Compared to Warfarin (COUMADIN®) for the Prevention of Venous Thromboembolism Following Total Knee Arthroplasty  This Clinical Study Report describes the methods and results for the confirmation of safety and efficacy study (EXULT B). The methods and results of the dose refinement study (EXULT A) are described in a separate Clinical Study Report.
SH-TPV-0001	Efficacy and safety of the oral thrombin inhibitor H 376/95 (ximelagatran), given to patients with acute deep venous thrombosis, an international dose-finding study (THRIVE I)
SH-TPV-0002/SH-TPV-0005	Efficacy and safety of the oral direct thrombin inhibitor ximelagatran versus standard therapy (enoxaparin and warfarin) for acute, symptomatic deep vein thrombosis with or without pulmonary embolism. A double-blind, international study (THRIVE Treatment)
SH-TPV-0003	Oral Thrombin Inhibitor Ximelagatran given to Patients as Prolonged Prophylaxis after a Six-month Anticoagulation Treatment for Venous Thromboembolism. An International Multicentre Double-blind Placebo Controlled Study (THRIVE III)