NCT00787150

Brief Summary

To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
222

participants targeted

Target at P75+ for phase_2 atrial-fibrillation

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 5, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 7, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

March 6, 2013

Completed
Last Updated

May 1, 2013

Status Verified

April 1, 2013

Enrollment Period

1.3 years

First QC Date

November 5, 2008

Results QC Date

January 29, 2013

Last Update Submit

April 23, 2013

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period

    Major bleeding event was acute clinically overt bleeding accompanied by decrease in hemoglobin of 2 g/dL or more over a 24-hour period, transfusion of 2 or more units of packed red blood cells, or bleeding that occurs in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Clinical relevant non-major bleeding was acute or sub-acute clinically overt bleeding that does not satisfy the criteria for major bleeding and that leads to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.

    Baseline to Week 12

Secondary Outcomes (6)

  • Number of Participants With Total Bleeding Events During the Treatment Period

    Baseline to Week 12

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

    Baseline to Week 12

  • Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period

    Baseline to Week 12

  • Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period

    Baseline to Week 12

  • Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period

    Baseline to Week 12

  • +1 more secondary outcomes

Other Outcomes (7)

  • Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban

    0, 2, 4 hours postdose at Week 1 and Week 8

  • Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban

    Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

  • Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban

    Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8

  • +4 more other outcomes

Study Arms (3)

Apixaban 5mg BID

EXPERIMENTAL
Drug: Apixaban

Apixaban 2.5mg BID

EXPERIMENTAL
Drug: Apixaban

Warfarin

ACTIVE COMPARATOR
Drug: Warfarin sodium

Interventions

ApixabanDRUG

Apixaban 5 mg tablet BID for 12 weeks

Apixaban 5mg BID
Warfarin sodiumDRUG

At each visit, the subject to take appropriate Warfarin tablet (on investigator's order) once a day every morning for 12 weeks

Warfarin

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 20 years outpatient (regardless of sex)
  • Patients diagnosed as non-valvular atrial fibrillation (NVAF)
  • One or more following risks of stroke.

You may not qualify if:

  • Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
  • Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
  • Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Location

Pfizer Investigational Site

Seto, Aichi-ken, Japan

Location

Pfizer Investigational Site

Touon, Ehime, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Pfizer Investigational Site

Ōgaki, Gifu, Japan

Location

Pfizer Investigational Site

Isesaki, Gunma, Japan

Location

Pfizer Investigational Site

Shibukawa, Gunma, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Higashiibaraki-gunn Ibarakimachi, Ibaraki, Japan

Location

Pfizer Investigational Site

Zentsujichó, Kagawa-ken, Japan

Location

Pfizer Investigational Site

Kawasaki, Kanagawa, Japan

Location

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Location

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Location

Pfizer Investigational Site

Minato-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinjuku-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Iwakuni, Yamaguchi, Japan

Location

Related Publications (1)

  • Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14.

    PMID: 21670542DERIVED

Related Links

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

apixabanWarfarin

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

4-HydroxycoumarinsCoumarinsBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Results Point of Contact

Title
Pfizer ClinicalTrials.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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2008

First Posted

November 7, 2008

Study Start

June 1, 2008

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 1, 2013

Results First Posted

March 6, 2013

Record last verified: 2013-04

Locations

JP(18)