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Ximelagatran prevented secondary venous thromboembolism

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 Q What is the long term efficacy and safety of ximelagatran after 6 months of standard anticoagulant therapy for secondary prevention of venous thromboembolism (VTE)?

Clinical impact ratings GP/FP/Primary care ★★★★★☆☆ IM/Ambulatory care ★★★★★★☆ Haematology ★★★★★★★


Embedded ImageDesign:

randomised placebo controlled trial (Thrombin Inhibitor in Venous Thromboembolism [THRIVE III]).

Embedded ImageAllocation:


Embedded ImageBlinding:

blinded (clinicians, patients, {data collectors, outcome assessors, and data analysts}).*

Embedded ImageFollow up period:

18 months.

Embedded ImageSetting

142 centres in 18 countries.

Embedded ImagePatients

1233 patients who were ⩾18 years of age with symptomatic, objectively confirmed deep venous thrombosis (DVT) or pulmonary embolism (PE) and had received anticoagulant therapy for 6 months with no recurrent VTE event. Exclusion criteria: indication for continuous anticoagulant therapy, haemoglobin level <9.0 g/dl, platelet count <90 000/mm3, pregnancy, lactation, expected survival <18 months, renal impairment, clinically important liver disease, or persistent elevation of the aminotransferase level >3 times the upper limit of normal.

Embedded ImageIntervention:

twice daily ximelagatran, 24 mg (n = 612), or placebo (n = 611) for 18 months. All patients discontinued anticoagulant therapy but did not begin study treatment until …

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