Primary objective: To determine if apixaban is noninferior to warfarin (INR target range 2.0-3.0) in the combined endpoint of stroke (ischemic or hemorrhagic) and systemic embolism, in subjects with AF and at lease one additional risk factor for…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary efficacy endpoint: The primary efficacy endpoint is the time to first
occurrence of confirmed stroke (ischemic or non-ischemic) or systemic embolism,
regardless of whether the subject is receiving treatment at the time of event.
Primary safety endpoint: The primary safety endpoint will be time to first
occurrence of confirmed major bleeding during the treatment period or 30 days
post-treatment if the event is a SAE.
Secondary outcome
The secondary efficacy endpoints will be: time to first occurrence of
confirmed: ischemic stroke, hemorrhagic stroke, systemic embolism, all cause
death and the composite of the combinations of all of these indications.
Secondary safety endpoints is a composite of confirmed major bleeding and
confirmed clinically relevant non-major bleeding.
Background summary
Apixaban is a potent, predictable and long-acting anticoagulant. In addition no
therapeutic monitoring is needed for safe dosage. Oral administration is
possible without an effect from food. Apixaban is easy to dose and showed a low
toxicity.
Research hypothesis: Apixaban is noninferior to warfarin for prevention of
stroke (ischemic or hemorrhagic) or systemic embolism in subjects with atrial
fibrillation (AF) and additional risk factor(s) for stroke.
Study objective
Primary objective: To determine if apixaban is noninferior to warfarin (INR
target range 2.0-3.0) in the combined endpoint of stroke (ischemic or
hemorrhagic) and systemic embolism, in subjects with AF and at lease one
additional risk factor for stroke.
Study design
Randomized, double-blind, active-controlled study with a double dummy design.
Intervention
Group 1: twice daily 5 m Apixaban and Warfarin placebo
Group 2: Warfarin dose titrated to a target INR range of 2.0 - 3.0 and twice
daily Apixaban-placebo.
Patients with a higher risk of bleeding will receive a lower dose of Apixaban
(2,5 mg twice daily).
Study burden and risks
Patient will have to visit the hospital 67 times in total for blood sampling,
physical exam, once a year an ECG and to discuss adverse events and concomitant
medication.
185 Chausee de la Hulpe
1170 Brussel
BE
185 Chausee de la Hulpe
1170 Brussel
BE
Listed location countries
Age
Inclusion criteria
1) Age >= 18 years
2) In atrial fibrillation or atrial flutter not due to reversible cause and documented by ECG at the time of enrollment OR If not in atrial fibrillation/flutter at the time of enrollment, must have atrial fibrillation/flutter documented on two separate occasions, not due to a reversible cause at least 2 weeks apart in the 12 months prior to enrollment.
3) One or more of the following risk factor(s) for stroke: a) Age 75 years or older, b) prior stroke, TIA or systemic embolus, c) Either symptomatic congestive heart failure within 3 months or left ventricular dysfunction with an LV ejection fraction (LVEF) <= 40%, d) Diabetes mellitus, e) hypertension requiring pharmacological treatment.
Exclusion criteria
1) Atrial fibrillation or flutter due to reversible causes.
2) Clinically significant mitral stenosis
3) Increased bleeding risk that is believed to be a contraindication to oral anticoagulation.
4) Conditions other than atrial fibrillation that require chronic anticoagulation.
5) Persistent, uncontrolled hypertension (systolic BP > 180 mmHg of diastolic BP > 100 mm Hg).
6) Active infective endocarditis.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-002147-91-NL |
| CCMO | NL16777.044.07 |