NCT00852397

Brief Summary

The purpose of this study is to assess the bleeding safety (the composite endpoint of major and clinically relevant non-major bleeding) of 2 doses of apixaban (2.5 mg BID and 5.0 mg BID) or placebo in combination with standard therapy (aspirin and /or additional antiplatelet therapy) over a 24 week treatment period in selected subjects with recent (≤7 days) acute coronary syndrome.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

18 active sites

Status
terminated

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

First Submitted

Initial submission to the registry

February 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2009

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.7 years until next milestone

Results Posted

Study results publicly available

August 29, 2013

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

1.7 years

First QC Date

February 26, 2009

Results QC Date

June 4, 2013

Last Update Submit

August 27, 2013

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Who Had Composite of International Society on Thrombosis and Haemostasis (ISTH)-Defined Major and Clinically-relevant Non-major (CRNM) Bleeding Events Occurring 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. CRNM bleeding was acute or sub-acute clinically overt bleeding that did not satisfy the criteria for major bleeding and that led to either hospital admission for bleeding, physician guided medical or surgical treatment for bleeding or a change in antithrombotic therapy.

    Week 0 to Week 24

Secondary Outcomes (5)

  • Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.

    Week 0 to Week 24

  • Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.

    Week 0 to Week 24

  • Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.

    Week 0 to Week 24

  • Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction, Unstable Angina and Stroke During 30 Days After Discontinuation of Therapy.

    For 30 days after Week 24 or the discontinuation of study drug

  • Percentage of Participants Who Had Composite of All-cause Death, Non-fatal Myocardial Infarction (MI), Unstable Angina, and Non-hemorrhagic Stroke Occurring During the Intended Treatment Period.

    From the day of randomization to the later date of either 2-days after the last dose of study drug or Day 168/Week 24 after randomization day (or the study termination date [19 November 2010, Japan time])

Other Outcomes (2)

  • Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.

    Week 0 to Week 24

  • Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.

    Week 0 to Week 24

Study Arms (3)

Apixaban 2.5 mg

EXPERIMENTAL
Drug: Apixaban

Apixaban 5.0 mg

EXPERIMENTAL
Drug: Apixaban

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

ApixabanDRUG

Apixaban 2.5 mg tablet BID for 24 weeks

Apixaban 2.5 mg
PlaceboOTHER

Placebo tablet for 24 weeks

Placebo

Eligibility Criteria

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

You may qualify if:

  • Recent (≤ 7 days) ACS
  • Clinically stable, and receiving standard treatment (patients must be treated with aspirin ≤ 100 mg/day, with or without clopidogrel 75 mg/day or ticlopidine 200 mg/day) based on the physician's judgment)

You may not qualify if:

  • Scheduled/planned cardiac catheterization, PCI, CABG or other invasive procedure planned in the 24 weeks (within treatment period) following randomization
  • Persistent severe hypertension, defined as systolic blood pressure of ≥180 mm Hg or diastolic pressure of ≥110 mm Hg
  • Active bleeding or at high risk for bleeding (e.g., cirrhosis of the liver, any history of intracranial hemorrhage).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Pfizer Investigational Site

Kasuga, Fukuoka, Japan

Location

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Location

Pfizer Investigational Site

Gifu, Gifu, Japan

Location

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Location

Pfizer Investigational Site

Kure, Hiroshima, Japan

Location

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Location

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Location

Pfizer Investigational Site

Uji, Kyoto, Japan

Location

Pfizer Investigational Site

Ikoma, Nara, Japan

Location

Pfizer Investigational Site

Hirakata, Osaka, Japan

Location

Pfizer Investigational Site

Kawachi-Nagano, Osaka, Japan

Location

Pfizer Investigational Site

Matsubara, Osaka, Japan

Location

Pfizer Investigational Site

Osaka, Osaka, Japan

Location

Pfizer Investigational Site

Yao, Osaka, Japan

Location

Pfizer Investigational Site

Wako, Saitama, Japan

Location

Pfizer Investigational Site

Sunto, Shizuoka, Japan

Location

Pfizer Investigational Site

Minato-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Shinagawa, Tokyo, Japan

Location

Related Publications (1)

  • Ogawa H, Goto S, Matsuzaki M, Hiro S, Shima D; APPRAISE-J investigators. Randomized, double-blind trial to evaluate the safety of apixaban with antiplatelet therapy after acute coronary syndrome in Japanese patients (APPRAISE-J). Circ J. 2013;77(9):2341-8. doi: 10.1253/circj.cj-13-0209. Epub 2013 Jun 7.

    PMID: 23748920DERIVED

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

apixaban

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

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

February 26, 2009

First Posted

February 27, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

August 29, 2013

Results First Posted

August 29, 2013

Record last verified: 2013-08

Locations

JP(18)