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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 ★★★★★★★
METHODS
Design:
randomised placebo controlled trial (Thrombin Inhibitor in Venous Thromboembolism [THRIVE III]).
Allocation:
concealed.*
Blinding:
blinded (clinicians, patients, {data collectors, outcome assessors, and data analysts}†).*
Follow up period:
18 months.
Setting
142 centres in 18 countries.
Patients
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.
Intervention:
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 …