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A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients

NCT ID: NCT00852397

Last Updated: 2013-08-29

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Due to withdraw of global phase 3 study (APPRAISE-2) for safety issue, B0661004 Data monitoring committee (DMC) also recommended terminating this study. Therefore, Pfizer decided to stop this study.

Conditions

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Acute Coronary Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Apixaban 2.5 mg

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Apixaban 2.5 mg tablet BID for 24 weeks

Apixaban 5.0 mg

Group Type EXPERIMENTAL

Apixaban

Intervention Type DRUG

Apixaban 5.0 mg tablet BID for 24 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo tablet for 24 weeks

Interventions

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Apixaban

Apixaban 2.5 mg tablet BID for 24 weeks

Intervention Type DRUG

Apixaban

Apixaban 5.0 mg tablet BID for 24 weeks

Intervention Type DRUG

Placebo

Placebo tablet for 24 weeks

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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).
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Kasuga, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Gifu, Gifu, Japan

Site Status

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Site Status

Pfizer Investigational Site

Kure, Hiroshima, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Site Status

Pfizer Investigational Site

Uji, Kyoto, Japan

Site Status

Pfizer Investigational Site

Ikoma, Nara, Japan

Site Status

Pfizer Investigational Site

Hirakata, Osaka, Japan

Site Status

Pfizer Investigational Site

Kawachi-Nagano, Osaka, Japan

Site Status

Pfizer Investigational Site

Matsubara, Osaka, Japan

Site Status

Pfizer Investigational Site

Osaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Yao, Osaka, Japan

Site Status

Pfizer Investigational Site

Wako, Saitama, Japan

Site Status

Pfizer Investigational Site

Sunto, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Minato-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Shinagawa, Tokyo, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 23748920 (View on PubMed)

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0661004&StudyName=A%20study%20to%20evaluate%20the%20safety%20of%20Apixaban%20in%20Acute%20Coronary%20Syndrome%20%28ACS%29%20Japanese%20patients

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Other Identifiers

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B0661004

Identifier Type: -

Identifier Source: org_study_id