Clinical trial NCT00787150: A Phase 2 Study To Evaluate The Safety Of Apixaban In Atrial Fibrillation
Official title: A Phase 2b, Randomized, Partially Blind (Open Label Warfarin), Active-Controlled (Warfarin), Multicenter Study, To Evaluate The Safety And Efficacy In 2 Doses Of Apixaban In Comparison To Warfarin, Administered For 12 Weeks In Subjects With NVAF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Atrial Fibrillation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2008-11-07
Enrollment: 222
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: To assess the effect of two doses of Apixaban (2.5 mg BID and 5 mg BID) versus Warfarin on the composite endpoint of major and clinically relevant non-major bleeding during the treatment period.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 20 years outpatient (regardless of sex)
* Patients diagnosed as non-valvular atrial fibrillation (NVAF)
* One or more following risks of stroke.

Exclusion Criteria:

* Recent cerebral infarction (includes TIA) within 4 weeks of week 0.
* Subjects who have or are suspected to have a serious/hereditary bleeding tendency, such as disseminated intravascular coagulation syndrome (DIC), congenital platelet dysfunction and von Willebrand disease (those suspected from the family history are included).
* Subjects who have or are suspected to have a serious/hereditary thrombogenic tendency (those suspected from the family history are included) or those who require continuation of the Warfarin therapy.

Primary outcomes:
measure: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) or Clinically Relevant Non-major Bleeding Adjudicated by Clinical Event Committee During the Treatment Period
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Number of Participants With Total Bleeding Events During the Treatment Period
timeFrame: Baseline to Week 12
measure: Number of Participants With Major (Per International Society on Thrombosis and Haemostasis [ISTH] Criteria) Bleeding Events During the Treatment Period
timeFrame: Baseline to Week 12
measure: Number of Participants With Clinically Relevant Non-major Bleeding Events During the Treatment Period
timeFrame: Baseline to Week 12
measure: Number of Participants With Stroke or Systemic Embolism During the Intended Treatment Period
timeFrame: Baseline to Week 12
measure: Number of Participants With Stroke, Systemic Embolism, or All-Cause Death During the Intended Treatment Period
timeFrame: Baseline to Week 12
measure: Number of Participants With Myocardial Infarction or All-Cause Death During the Intended Treatment Period
timeFrame: Baseline to Week 12
Other outcomes:
measure: Mean Plasma Apixaban Concentration at Each Time Point in Participants Treated With Apixaban
timeFrame: 0, 2, 4 hours postdose at Week 1 and Week 8
measure: Mean Prothrombin Time (PT) at Each Time Point in Participants Treated With Apixaban
timeFrame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
measure: Mean Prothrombin Time-International Normalized Ratio (PT-INR) at Each Time Point in Participants Treated With Apixaban
timeFrame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
measure: Mean Activated Partial Thromboplastin Time (aPTT) at Each Time Point in Participants Treated With Apixaban
timeFrame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
measure: Mean Anti-Xa Activity (Apixaban Units) at Each Time Point in Participants Treated With Apixaban
timeFrame: Week 0, 0, 2, 4 hours postdose at Week 1 and Week 8
measure: Mean Prothrombin Fragment 1+2 (F1+2) at Each Time Point in Participants Treated With Warfarin or Apixaban
timeFrame: Week 0, Week 1, Week 8
measure: Mean D-Dimer at Each Time Point in Participants Treated With Warfarin or Apixaban
timeFrame: Week 0, Week 1, Week 8
Locations:
city: Nagoya
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Seto
country: Japan
facility: Pfizer Investigational Site
state: Aichi
city: Touon
country: Japan
facility: Pfizer Investigational Site
state: Ehime
city: Kitakyushu
country: Japan
facility: Pfizer Investigational Site
state: Fukuoka
city: Ogaki
country: Japan
facility: Pfizer Investigational Site
state: Gifu
city: Isezaki
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Shibukawa
country: Japan
facility: Pfizer Investigational Site
state: Gunma
city: Sapporo
country: Japan
facility: Pfizer Investigational Site
state: Hokkaido
city: Higashiibaraki-gunn Ibarakimachi
country: Japan
facility: Pfizer Investigational Site
state: Ibaraki
city: Zentsuji
country: Japan
facility: Pfizer Investigational Site
state: Kagawa
city: Kawasaki
country: Japan
facility: Pfizer Investigational Site
state: Kanagawa
city: Tsu
country: Japan
facility: Pfizer Investigational Site
state: Mie
city: Minato-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
city: Iwakuni
country: Japan
facility: Pfizer Investigational Site
state: Yamaguchi
city: Fukuoka
country: Japan
facility: Pfizer Investigational Site
city: Kumamoto
country: Japan
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Ogawa S, Shinohara Y, Kanmuri K. Safety and efficacy of the oral direct factor xa inhibitor apixaban in Japanese patients with non-valvular atrial fibrillation. -The ARISTOTLE-J study-. Circ J. 2011;75(8):1852-9. doi: 10.1253/circj.cj-10-1183. Epub 2011 Jun 14.