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

Last updated on October 4, 2018

FOR MORE INFORMATION
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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A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
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)
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Acute Coronary Syndrome
  • 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
  • Experimental: Apixaban 2.5 mg
    Intervention: Drug: Apixaban
  • Experimental: Apixaban 5.0 mg
    Intervention: Drug: Apixaban
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
151
December 2010
December 2010   (Final data collection date for primary outcome measure)

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).
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT00852397
B0661004
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Bristol-Myers Squibb
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2013

ICMJE     Data element required by the

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

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