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

NCT01780987 | Completed Phase 3 Results DMC

• 2 other identifiers: B0661024CV185160
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 20

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)

Conditions

Deep Vein Thrombosis; Pulmonary Embolism

Keywords

DVT; PE; VTE

Outcome Measures

Primary Outcomes (1)

• 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

  Major bleeding event was defined as an acute clinically overt bleeding accompanied by a decrease in hemoglobin of 2 g/dL or more, a transfusion of 4 or more units of packed red blood cells (a unit of packed red blood cells equal to about 200 cc), or bleeding that occurred in critical sites (e.g. intracranial). Fatal bleeding was also defined as a major bleeding event. CRNM bleeding event was defined as an acute clinically overt bleeding that did not satisfy the definition of major bleeding and that led to either hospitalization, physician guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.

  Baseline to Week 24

Secondary Outcomes (5)

• 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

  Baseline to Week 24

• Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Proximal Deep Venous Thrombosis (DVT)

  Baseline to Week 24

• Number of Participants With Adjudicated Thrombotic Burden Worsened in Acute Symptomatic Pulmonary Embolism (PE)

  Baseline to Week 24

• Number of Participants With Adjudicated Major Bleeding Events ［Per International Society on Thrombosis and Homeostasis (ISTH) Definition］During the Treatment Period

  Baseline to Week 24

• Number of Participants With Adjudicated All Bleeding Events During the Treatment Periods

  Baseline to Week 24

Study Arms (2)

Apixaban

EXPERIMENTAL

Drug: Apixaban

UFH/Warfarin

ACTIVE COMPARATOR

Drug: Unfractionated Heparin (UFH); Drug: Warfarin

Interventions

Apixaban DRUG

10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)

Apixaban

Unfractionated Heparin (UFH) DRUG

Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more

UFH/Warfarin

Warfarin DRUG

Dosing for 24 weeks to target INR range between 1.5-2.5

UFH/Warfarin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead
• Bristol-Myers Squibb: collaborator

Study Sites (20)

Aichi Medical University Hospital

Nagakute, Aichi-ken, 480-1195, Japan

Location

Toho University Sakura Medical Center

Sakura, Chiba, 285-8741, Japan

Location

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

Location

Fukushima Medical University Hospital

Fukushima, Fukushima, 960-1295, Japan

Location

Hiroshima General Hospital

Hatsukaichi, Hiroshima, 738-8503, Japan

Location

Teine Keijinkai Hospital

Sapporo, Hokkaido, 006-8555, Japan

Location

Kanazawa Medical University Hospital

Kahoku-gun, Ishikawa-ken, 920-0293, Japan

Location

Yokohama Minami Kyousai Hospital

Yokohama, Kanagawa, 236-0037, Japan

Location

National Hospital Organization Yokohama Medical Center

Yokohama, Kanagawa, 245-8575, Japan

Location

Kumamoto University Hospital

Kumamoto, Kumamoto, 860-8556, Japan

Location

Saiseikai Kumamoto Hospital

Kumamoto, Kumamoto, 861-4193, Japan

Location

Mie University Hospital

Tsu, Mie-ken, 514-8507, Japan

Location

National Hospital Organization Okayama Medical Center

Okayama, Okayama-ken, 701-1192, Japan

Location

Kinki University Hospital

Sayama, Osaka, 589-8511, Japan

Location

National Cerebral and Cardiovascular Center Hospital

Suita-shi, Osaka, 565-8565, Japan

Location

St. Luke's International Hospital

Chuo-ku, Tokyo, 104-8560, Japan

Location

Nihon University Itabashi Hospital

Itabashi-ku, Tokyo, 173-8610, Japan

Location

National Hospital Organization Tokyo Medical Center

Meguro-ku, Tokyo, 152-8902, Japan

Location

Japanese Red Cross Musashino Hospital

Musashino, Tokyo, 180-8610, Japan

Location

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, 160-0023, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Venous Thrombosis; Pulmonary Embolism

Interventions

apixaban; Heparin; Warfarin

Condition Hierarchy (Ancestors)

Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Pfizer Clinical Trials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.gov_inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2013
• First Posted: January 31, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 23, 2016
• Results First Posted: June 23, 2016

Record last verified: 2016-05

Locations

JP (20)