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

Last updated on November 10, 2019

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Study Location
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Acute Coronary Syndrome
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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).

NCT00852397
Pfizer
Terminated
A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients

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Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
Official Title  ICMJE A Phase 2, Placebo-Controlled, Randomized, Double-Blinded, Multicenter, Study To Evaluate The Bleeding Profile Of 2.5 Mg And 5.0 Mg BID Apixaban In Combination With Standard Therapy In Patients With Recent (?7 Days) Acute Coronary Syndrome (ACS)
Brief SummaryThe 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 DescriptionDue 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Acute Coronary Syndrome
Intervention  ICMJE
  • Drug: Apixaban
    Apixaban 2.5 mg tablet BID for 24 weeks
  • Drug: Apixaban
    Apixaban 5.0 mg tablet BID for 24 weeks
  • Other: Placebo
    Placebo tablet for 24 weeks
Study Arms  ICMJE
  • Experimental: Apixaban 2.5 mg
    Intervention: Drug: Apixaban
  • Experimental: Apixaban 5.0 mg
    Intervention: Drug: Apixaban
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Publications *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. Epub 2013 Jun 7.


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: March 22, 2011)
151
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2009)
170
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion DateDecember 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00852397
Other Study ID Numbers  ICMJE B0661004
Has Data Monitoring CommitteeYes
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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