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

Purpose

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.

Condition	Intervention	Phase
Acute Coronary Syndrome	Drug: Apixaban Other: Placebo	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	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)

Resource links provided by NLM:

MedlinePlus related topics: Angina

Drug Information available for: Apixaban

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

Incidence of major bleeding and clinically relevant non-major bleeding evaluated by ISTH criteria during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Incidence of all bleeding (major bleeding evaluated by ISTH criteria, clinically relevant non-major bleeding, and minor bleeding) occurring through Week 4 and during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Incidence of all bleeding (major bleeding and minor bleeding evaluated by TIMI criteria) during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Incidence of major bleeding during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Composite of all-cause death, non-fatal myocardial infarction, severe unstable angina and stroke during 30 days after discontinuation of therapy [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Other safety outcome measures will also be assessed, including serious and non-serious AEs and changes in standard clinical laboratory test results [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]
Composite of all-cause death, non-fatal myocardial infarction, severe unstable angina, and non-hemorrhagic stroke occurring during the treatment period [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment:	151
Study Start Date:	April 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Apixaban 2.5 mg	Drug: Apixaban Apixaban 2.5 mg tablet BID for 24 weeks
Experimental: Apixaban 5.0 mg	Drug: Apixaban Apixaban 5.0 mg tablet BID for 24 weeks
Placebo Comparator: Placebo	Other: Placebo Placebo tablet for 24 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852397

Locations

Japan
Pfizer Investigational Site
Kasuga, Fukuoka, Japan
Pfizer Investigational Site
Kitakyusyu, Fukuoka, Japan
Pfizer Investigational Site
Kure, Hiroshima, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Uji, Kyoto, Japan
Pfizer Investigational Site
Ikoma, Nara, Japan
Pfizer Investigational Site
Hirakata, Osaka, Japan
Pfizer Investigational Site
Kawachinagano, Osaka, Japan
Pfizer Investigational Site
Matsubara, Osaka, Japan
Pfizer Investigational Site
Yao, Osaka, Japan
Pfizer Investigational Site
Wako, Saitama, Japan
Pfizer Investigational Site
Sunto, Shizuoka, Japan
Pfizer Investigational Site
Minato-Ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa, Tokyo, Japan
Pfizer Investigational Site
Gifu, Japan
Pfizer Investigational Site
Hiroshima, Japan
Pfizer Investigational Site
Kumamoto, Japan
Pfizer Investigational Site
Osaka, Japan

Sponsors and Collaborators

Pfizer

Bristol-Myers Squibb

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00852397 History of Changes
Other Study ID Numbers:	B0661004
Study First Received:	February 26, 2009
Last Updated:	March 22, 2011
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:

Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013