The purpose of this clinical research is to learn if apixaban is more effective than Acetylsalicyclic Acid (ASA) in preventing strokes associated with subjects who have atrial fibrillation. The safety of this treatment will also be studied.
- Conditions
- Patients with atrial fibrillation and at least one additional risk factor for stroke who have failed or are unsuitable for vitamin K antagonist therapyMedDRA version: 14.1Level: SOCClassification code 10047065Term: Vascular disordersSystem Organ Class: 10047065 - Vascular disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2007-001557-26-IT
- Lead Sponsor
- Bristol Myers Squibb International Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 6160
1) Signed written informed consent form 2) Target Population b) Permanent, paroxysmal or persistent atrial fibrillation documented by 12 lead ECG on the day of screening OR If not in atrial fibrillation at screening, atrial fibrillation must be documented in the 6 months prior to enrollment by 12 lead ECG, or as an episode at least 5 minutes in duration on a rhythm strip or Holter recording. Pacemaker or ICD electrogram recordings may be used to document AF but the duration of atrial fibrillation must be at least 30 minutes if this is the only documentation of AF. c) Presence of at least one of the following risk factors for stroke: prior stroke or TIA;Age >/= 75 years; Arterial hypertension on treatment; Diabetes mellitus;Heart failure. NYHA Class 2 or greater at time of enrollment;Left ventricular ejection fraction 35% or less, documented within 6 months of enrollment; Documented peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio < 0.9) d) The patient is not currently receiving vitamin K antagonist therapy for one of the following reasons: Previous vitamin K antagonist therapy has been demonstrated to be unsuitable and its use has been discontinued (e.g., poor anticoagulant control, adverse events, need for other treatments that may interact with VKA, patient unable or unwilling to adhere to dose or INR monitoring instructions); Vitamin K antagonist therapy has not been previously used but would be expected to be unsuitable (e.g., unlikely to comply with dosing or monitoring requirement, need for other treatments which may interact with VKA, unlikely to adhere to restrictions on alcohol, diet or nonprescription medications, risk of VKA therapy considered to outweigh the risk of stroke or systemic embolism, patient is unwilling to take VKA). 3) Age and Sex e) Men and women >/= 50 years of age LONG TERM OPEN LABEL EXTENSION 1) Signed Written Informed a) All subjects must provide signed written informed consent to participate in the Long-Term Open-Label Extension 2) Target Population a) All subjects must be receiving double-blind study medication (i.e., not having permanently or temporarily [for >30 days] discontinued study medication) at the time they present for their last double-blind study visit (Month 36/EOT).
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1478
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4682
The following exclusion criteria are the changed ones. For the rest part of exclusion criteria refer to protocol numebr 4 issued on 22/06/2011 Patients entering the Long-Term Open-Label Extension who do not initially meet laboratory criteria but have qualifying values at the time of the Month LTOLE 1 visit may continue to participate in the LTOLE. If the value of serum creatinine at Month 1 is > 221umol/L or > 2.5 mg/dL you should do the following: • Patient should be instructed to temporarily discontinue open-label apixaban until renal function recovers • Repeat serum creatinine tests should be performed (locally or centrally via unscheduled lab request) to confirm recovery of renal function before considering restarting apixaban If repeat test results show that value is < 221 umol/L or 2.5 mg/dL, open-label apixaban may be resumed as long as the patient has not temporarily discontinued study drug for > 60 days. If patient has temporarily discontinued study drug for > 60 days, they are no longer eligible to participate in the LTOLE phase of the trial. Study drug must permanently discontinued and the Final LTOLE Visit must occur.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if apixaban 5 mg BID (2.5 mg BID in selected patients) is superior to ASA (81 to 324 mg QD) for preventing the composite outcome of stroke or systemic embolism in patients with atrial fibrillation and at least one additional risk factor for stroke who have failed or are unsuitable for vitamin K antagonist therapy;Secondary Objective: To determine if, in the same patients, apixaban is superior to ASA for the prevention of the composite outcome of: -Stroke, systemic embolism, myocardial infarction or vascular death (major vascular events);Primary end point(s): The following outcomes will be examined: - Primary efficacy outcome: time to the composite of stroke or systemic embolism - Primary safety outcome: time to major bleeding - Secondary Efficacy Outcome: time to stroke, systemic embolism, myocardial infarction or vascular death (major vascular events);Timepoint(s) of evaluation of this end point: Time to first occurrence
- Secondary Outcome Measures
Name Time Method Secondary end point(s): The secondary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted Ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction or vascular deaths. CV185-048-AF-IT-V10-CA.pdf 01-Jun-2012;Timepoint(s) of evaluation of this end point: Time to first occurrence