Clinical trial NCT01780987: AStudy To Evaluate Safety And Eficacy Of Apixaban In Japanese Acute Deep Vein Thrombosis (DVT) And Pulmonary Embolism (PE) Patients
Official title: Active-control, Multicenter, Randomized, Open-label, Safety And Efficacy Study Evaluating The Use Of Apixaban In The Treatment Of Symptomatic Deep Vein Thrombosis And Pulmonary Embolism In Japanese
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Deep Vein Thrombosis
Pulmonary Embolism
Keywords: DVT
PE
VTE
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2013-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］ or Clinically Relevant Non-major (CRNM) Bleeding Events Adjudicated by Clinical Event Committee During the Treatment Period
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Number of Participants With Adjudicated Recurrent Symptomatic Venous Thromboembolism (VTE) ［Nonfatal Deep Venous Thrombosis (DVT) or Nonfatal Pulmonary Embolism (PE)］ or VTE-Related Death During the Intended Treatment Period
timeFrame: Baseline to Week 24
measure: Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)
timeFrame: Baseline to Week 24
measure: Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)
timeFrame: Baseline to Week 24
measure: Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period
timeFrame: Baseline to Week 24
measure: Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital
state: Aichi
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
state: Chiba
city: Kitakyusyu
country: Japan
facility: Kokura Memorial Hospital
state: Fukuoka
city: Hatsukaichi
country: Japan
facility: Hiroshima General Hospital
state: Hiroshima
city: Sapporo
country: Japan
facility: Teine Keijinkai Hospital
state: Hokkaido
city: Kahoku-gun
country: Japan
facility: Kanazawa Medical University Hospital
state: Ishikawa
city: Yokohama
country: Japan
facility: Yokohama Minami Kyousai Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: National Hospital Organization Yokohama Medical Center
state: Kanagawa
city: Tsu
country: Japan
facility: Mie University Hospital
state: MIE
city: Okayama City
country: Japan
facility: National Hospital Organization Okayama Medical Center
state: Okayama
city: Osakasayama
country: Japan
facility: Kinki University Hospital
state: Osaka
city: Suita-shi
country: Japan
facility: National Cerebral and Cardiovascular Center Hospital
state: Osaka
city: Chuo-ku
country: Japan
facility: St. Luke's International Hospital
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Nihon University Itabashi Hospital
state: Tokyo
city: Meguro-ku
country: Japan
facility: National Hospital Organization Tokyo Medical Center
state: Tokyo
city: Musashino
country: Japan
facility: Japanese Red Cross Musashino Hospital
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital
state: Tokyo
city: Fukushima
country: Japan
facility: Fukushima Medical University Hospital
city: Kumamoto
country: Japan
facility: Kumamoto University Hospital
city: Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: