Clinical Trials List
2008-06-01 - 2011-05-31
Phase III
Terminated6
Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or are Unsuitable for Vitamin K Antagonist Treatmet: A Randomized Double Blind Trial
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hsiang Chun Lee Division of Cardiovascular Diseases
- 溫文才 Division of Cardiovascular Diseases
- 蘇河名 Division of Cardiovascular Diseases
- 李智雄 Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- 李坤泰 Division of Cardiovascular Diseases
- 黃智興 Division of Cardiovascular Diseases
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- 顏學偉 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 李愛先 Division of Cardiovascular Diseases
- Yung-Kuo Lin Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Cheng-Han Lee Division of Cardiovascular Diseases
- Ju-Yi Chen Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period
2.Secondary Outcome Measures :
1)Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period.
2)Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death.
3)Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period .
4)Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period.
5)Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome.
6)Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality.
7)Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued).
8)Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued).
Inclution Criteria
2.Age of 50 years or older
3.Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
4.At least 1 of the following risk factors for stroke:
1)Prior stroke or transient ischemic attack
2)Age of 75 years or older
3)Arterial hypertension on treatment
4)Diabetes mellitus
5)Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
6)Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
7)Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
5.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
Exclusion Criteria
2.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
3.Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
4.Valvular disease requiring surgery
5.Planned ablation procedure for atrial fibrillation to be performed within 3 months
6.Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
7.Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:
1)Active peptic ulcer disease
2)Platelet count <100,000/mm^3 or hemoglobin <10g/dL
3)Recent stroke (within 10 days)
4)Documented hemorrhagic tendencies or blood dyscrasias
8.Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
9.Severe comorbid condition with life expectancy <1 year
10.Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
11.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)
12.Allergy or adverse reaction to acetylsalicylic acid
Required treatment with a thienopyridine (clopidogrel or ticlopidine)
13.Prisoners or participants who are compulsory detained (involuntarily incarcerated)
14.Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
15.Patients who are compulsorily detained for treatment for a psychiatric or physical illness
The Estimated Number of Participants
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Taiwan
80 participants
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Global
5600 participants
