Clinical trial NCT00852397: 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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2009-02-27
Enrollment: 151
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: 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.
timeFrame: Week 0 to Week 24
Secondary outcomes:
measure: Percentage of Participants Who Had One or More All Bleeding Occurring During the Treatment Period.
timeFrame: Week 0 to Week 24
measure: Percentage of Participants Who Had Major Bleeding Occurring During the Treatment Period Per International Society on Thrombosis and Haemostasis (ISTH) Definitions.
timeFrame: Week 0 to Week 24
measure: Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI)-Defined Major Bleeding Occurring During the Treatment Period.
timeFrame: Week 0 to Week 24
measure: 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.
timeFrame: For 30 days after Week 24 or the discontinuation of study drug
measure: 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.
timeFrame: 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])
Other outcomes:
measure: Percentage of Participants Who Had International Society on Thrombosis and Haemostasis (ISTH)-Defined Individual Bleeding Endpoints (Clinically-relevant Non-major [CRNM] or Minor Bleeding) During the Treatment Period.
timeFrame: Week 0 to Week 24
measure: Percentage of Participants Who Had Thrombolysis in Myocardial Infarction (TIMI) Defined-individual Bleeding Endpoints (Minor or Minimal Bleeding) During the Treatment Period.
timeFrame: Week 0 to Week 24
Locations:
city: Kasuga
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kitakyusyu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Kure
country: Japan
facility: Pfizer Investigational Site
state: Hiroshima
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Uji
country: Japan
facility: Pfizer Investigational Site
state: Kyoto
city: Ikoma
country: Japan
facility: Pfizer Investigational Site
state: Nara
city: Hirakata
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Kawachinagano
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Matsubara
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Yao
country: Japan
facility: Pfizer Investigational Site
state: Osaka
city: Wako
country: Japan
facility: Pfizer Investigational Site
state: Saitama
city: Sunto
country: Japan
facility: Pfizer Investigational Site
state: Shizuoka
city: Minato-Ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Gifu
country: Japan
facility: Pfizer Investigational Site
city: Hiroshima
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
city: Osaka
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.