Switching Study From Warfarin to Rivaroxaban

PHASE1CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

November 30, 2008

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Venous Thrombosis
Interventions
DRUG

Warfarin (Coumadin)

Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Days 0 to 3: 20 mg rivaroxaban once daily

DRUG

Placebo

Days 0 to 3: 1 tablet placebo, identical to active tablet

DRUG

Vitamin K (Konakion)

Day 5: 10 mg vitamin K (Konakion) once daily

Trial Locations (2)

41061

Mönchengladbach

51063

Cologne

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

lead

Bayer

INDUSTRY