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

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

Overview[ - collapse ][ - ]

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	Acute Coronary Syndrome
Intervention	Drug: Apixaban Drug: Apixaban Other: Placebo
Phase	Phase 2
Sponsor	Pfizer
Responsible Party	Pfizer
ClinicalTrials.gov Identifier	NCT00852397
First Received	February 26, 2009
Last Updated	August 27, 2013
Last verified	August 2013

Tracking Information[ + expand ][ + ]

First Received Date	February 26, 2009
Last Updated Date	August 27, 2013
Start Date	April 2009
Estimated Primary Completion Date	December 2010
Current Primary Outcome Measures	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. [Time Frame: Week 0 to Week 24] [Designated as safety issue: Yes]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.
Current Secondary Outcome Measures	Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period. [Time Frame: Week 0 to Week 24] [Designated as safety issue: Yes]All bleeding included major bleeding (including fatal bleeding), clinically-relevant non-major (CRNM) bleeding, and minor bleeding per international society on thrombosis and haemostasis (ISTH) definitions. Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions. [Time Frame: Week 0 to Week 24] [Designated as safety issue: Yes]Major bleeding event was defined as an 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 occured in critical site (e.g., intracranial). Fatal bleeding was also major bleeding event. Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period. [Time Frame: Week 0 to Week 24] [Designated as safety issue: Yes]TIMI major bleeding event was difined as an intracranial bleeding or clinically overt bleeding (including bleeding evident on imaging studies) associated with a >= 5 gm/dL fall in hemoglobin or a 15% fall in hematocrit from baseline, accounting for the effect of transfusions (1 unit packed red blood cells = 1 gm/dL hemoglobin = 3% hematocrit). 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. [Time Frame: For 30 days after Week 24 or the discontinuation of study drug] [Designated as safety issue: Yes] 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. [Time Frame: 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])] [Designated as safety issue: No]Intended treatment period for efficacy endpoints was defined as a period starting on the day of randomization and ending at 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]).

Descriptive Information[ + expand ][ + ]

Brief Title	A Study to Evaluate the Safety of Apixaban in Acute Coronary Syndrome (ACS) Japanese Patients
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)
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.
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.
Study Type	Interventional
Study Phase	Phase 2
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Acute Coronary Syndrome
Intervention	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 Arm (s)	Experimental: Apixaban 2.5 mg Experimental: Apixaban 5.0 mg Placebo Comparator: Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	151
Estimated Completion Date	December 2010
Estimated Primary Completion Date	December 2010
Eligibility 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).
Gender	Both
Ages	20 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Japan

Administrative Information[ + expand ][ + ]

NCT Number	NCT00852397
Other Study ID Numbers	B0661004
Has Data Monitoring Committee	Yes
Information Provided By	Pfizer
Study Sponsor	Pfizer
Collaborators	Bristol-Myers Squibb
Investigators	Study Director: Pfizer CT.gov Call Center Pfizer
Verification Date	August 2013

Locations[ + expand ][ + ]

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