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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00496769




Registration number
NCT00496769
Ethics application status
Date submitted
2/07/2007
Date registered
4/07/2007
Date last updated
15/06/2018

Titles & IDs
Public title
A Phase III Study of Apixaban in Patients With Atrial Fibrillation
Scientific title
Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial
Secondary ID [1] 0 0
CV185-048
Universal Trial Number (UTN)
Trial acronym
AVERROES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Apixaban
Treatment: Drugs - Acetylsalicylic acid

Experimental: Apixaban -

Active Comparator: Acetylasalicylic acid -


Treatment: Drugs: Apixaban
Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks

Treatment: Drugs: Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period - Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)
Timepoint [1] 0 0
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [1] 0 0
Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period - Event rate=percent of participants with an event divided by the total participants in the arm.
Timepoint [1] 0 0
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [2] 0 0
Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death - Event rate=percent of participants with an event divided by the total participants in the arm.
Timepoint [2] 0 0
Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [3] 0 0
Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period - Event rate=percent of participants with an event divided by the total participants in the arm.
Timepoint [3] 0 0
First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
Secondary outcome [4] 0 0
Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period - Event rate=percent of participants with an event divided by the total participants in the arm.
Timepoint [4] 0 0
Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary outcome [5] 0 0
Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome - AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.
Timepoint [5] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary outcome [6] 0 0
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality - BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value =8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/µL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/µL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN =BL= ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN=BL=ULN; neutrophils (absolute), low: <1.0*10^3 cells/µL; eosinophils (absolute), high: >0.750*10^3 cells/µL; basophils (absolute), high: >0.4*10^3 cells/µL; monocytes (absolute), high: 2*10^3 cells/µL; lymphocytes (absolute), low if <0.75*10^3 cells/µL, high if >7.50*10^3 cells/µL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.
Timepoint [6] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary outcome [7] 0 0
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) - LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN =BL=ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN=BL=ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN=BL=ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN=BL=ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN=BL =ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN=BL=ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN=BL=ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN=BL=ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN=BL=ULN, high if >1.25*BL when BL>ULN or >ULN
Timepoint [7] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary outcome [8] 0 0
Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) - ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN=BL=ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN=BL=ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN=BL=ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN=BL=ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN=BL=ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN=BL=ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL=ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: =2 if BL=missing,=0 or =0.5 or if =3 if BL=1, or if =4 and BL=2.
Timepoint [8] 0 0
First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

Eligibility
Key inclusion criteria
Key

- Male and female

- Age of 50 years or older

- Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6
months prior to enrollment) documented by 12-lead electrocardiogram)

- At least 1 of the following risk factors for stroke:

- Prior stroke or transient ischemic attack

- Age of 75 years or older

- Arterial hypertension on treatment

- Diabetes mellitus

- Heart failure (New York Health Authority Class 2 or greater at time of
enrollment)

- Left ventricular ejection fraction of 35% or less, documented within 6 months of
enrollment

- Peripheral arterial disease (previous arterial revascularization, limb or foot
amputation, or current intermittent claudication with ankle-arm systolic blood
pressure ratio <0.9)

- Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

- Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued

- Vitamin K antagonist therapy not previously used but expected unsuitable

Key
Minimum age
50 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Women who are pregnant or breast feeding

- Women of child bearing potential who are unwilling to meet the study requirements for
pregnancy testing or are unwilling or unable to use an acceptable method to avoid
pregnancy

- Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis

- Valvular disease requiring surgery

- Planned ablation procedure for atrial fibrillation to be performed within 3 months

- Conditions other than atrial fibrillation that require chronic anticoagulation (such
as, prosthetic mechanical heart valve, venous thromboembolism)

- Patients with serious bleeding in the last 6 months or at high risk for bleeding,
including but not limited to those with:

- Active peptic ulcer disease

- Platelet count <100,000/mm^3 or hemoglobin <10g/dL

- Recent stroke (within 10 days)

- Documented hemorrhagic tendencies or blood dyscrasias

- Current alcohol or drug abuse or psychosocial reasons that make study participation
impractical

- Severe comorbid condition with life expectancy <1 year

- Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a
calculated creatinine clearance <25 mL/min is excluded

- Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of
normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative
causative factor [such as Gilbert's syndrome] is identified)

- Allergy or adverse reaction to acetylsalicylic acid

- Required treatment with a thienopyridine (clopidogrel or ticlopidine)

- Prisoners or participants who are compulsory detained (involuntarily incarcerated)

- Use of an investigational drug or device within the past 30 days or prior
randomization into an apixaban clinical study

- Patients who are compulsorily detained for treatment for a psychiatric or physical
illness

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Coffs Harbour
Recruitment hospital [2] 0 0
Local Institution - Concord
Recruitment hospital [3] 0 0
Local Institution - Gosford
Recruitment hospital [4] 0 0
Local Institution - Kingswood
Recruitment hospital [5] 0 0
Local Institution - Auchenflower
Recruitment hospital [6] 0 0
Local Institution - Kippa Ring
Recruitment hospital [7] 0 0
Local Institution - Milton
Recruitment hospital [8] 0 0
Local Institution - Woolloongabba
Recruitment hospital [9] 0 0
Local Institution - Geelong
Recruitment hospital [10] 0 0
Local Institution - Joondalup
Recruitment postcode(s) [1] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [2] 0 0
2139 - Concord
Recruitment postcode(s) [3] 0 0
2250 - Gosford
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
4066 - Auchenflower
Recruitment postcode(s) [6] 0 0
4021 - Kippa Ring
Recruitment postcode(s) [7] 0 0
4064 - Milton
Recruitment postcode(s) [8] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [9] 0 0
3220 - Geelong
Recruitment postcode(s) [10] 0 0
6027 - Joondalup
Recruitment outside Australia
Country [1] 0 0
United States of America
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Alabama
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Arizona
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Illinois
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Indiana
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Louisiana
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Bogota
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Brno
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Jindrichuv Hradec
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Kladno
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Kromeriz
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Ostrava
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Praha 1
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Praha 5
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Czechia
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Pribram
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Slany
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Usti Nad Orlici
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Denmark
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Arhus C
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Esbjerg
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Frederiksberg
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Espoo
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Helsinki
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Jyvaskyla
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Kuopio
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Tampere
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Paris Cedex 18
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Sisteron
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Toulon Cedex 09
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Germany
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Berlin
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Bonn
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Essen
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Frankfurt Am Main
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Germany
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Halle/saale
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Germany
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Hamburg
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Germany
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Heidelberg
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Kassel
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Koln
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Germany
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Leipzig
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Germany
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Magdeburg
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Germany
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Mainz
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Germany
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Mannheim
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Germany
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Papenburg
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Germany
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Regensburg
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Germany
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Riesa
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Germany
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Witten
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Germany
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Wolmirstedt
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Greece
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Athens
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Greece
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Larissa
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Greece
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Thiva
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Hong Kong
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NEW Territories
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Hong Kong
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Chai Wan
Country [138] 0 0
Hong Kong
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Hong Kong
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India
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Andhra Pradesh
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India
State/province [140] 0 0
Karnataka
Country [141] 0 0
India
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Maharashtra
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India
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical research study is to determine whether apixaban is more
effective than acetylsalicylic acid in the prevention of strokes associated with patients
with atrial fibrillation. The safety of this treatment will also be studied.
Trial website
https://clinicaltrials.gov/show/NCT00496769
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications