AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pulmonary Embolism; Deep Vein Thrombosis

Treatments: Drug: Warfarin; Drug: Apixaban; Drug: Unfractionated Heparin (UFH)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01780987

B0661024

CV185160 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate safety of apixaban in Japanese acute DVT/PE subjects when symptomatic DVT/PE subjects are treated with 10 mg BID apixaban for 7 days as initial therapy followed by 5 mg BID apixaban for 23 weeks as long-term therapy (total treatment period is 24 weeks)

Enrollment: 80 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Acute symptomatic proximal DVT with evidence of proximal thrombosis
• Acute symptomatic PE with evidence of thrombosis in segmental or more proximal branches

Exclusion criteria

• Active bleeding or high risk for bleeding contraindicating treatment with UFH and a VKA.
• Uncontrolled hypertension: systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg
• Subjects requiring dual anti-platelet therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Apixaban

Experimental group

Treatment:

Drug: Apixaban

UFH/Warfarin

Active Comparator group

Treatment:

Drug: Unfractionated Heparin (UFH)

Drug: Warfarin