Stroke Clinical Trial
Official title:
Canadian Pradaxa Acute Stroke Safety Study
Study Design:
This is a multicentre, prospective, open-label, single arm, phase IV registry study. No
additional procedures are included in the study. Standard clinical data will be collected.
This will include a physical examination and NIHSS score assessment at baseline. In addition,
all neuro-imaging will be collected. Standard imaging includes a non-contrast CT brain at
baseline and 7±2 days post-treatment. Repeat NIHSS score assessment at the time of the 7 day
CT scan. Repeat clinical and NIHSS score assessment 30 days post-enrolment will also be
collected when performed as part of standard care.
Study Objectives:
1. Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients
with atrial fibrillation.
2. Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of
dabigatran treatment following stroke/TIA
3. Determine the effect of asymptomatic hemorrhagic transformation on functional and
neurological outcome at 30 days.
Study Aim and Design:
The primary aim of the CPASS registry is to demonstrate the safety of early anticoagulation
with dabigatran following cardioembolic stroke. CPASS is a prospective open label single arm
observational study. Safety will be established by demonstrating low rates of hemorrhage in
this setting.
Administrative Structure:
CPASS is a Canadian Stroke Consortium led study. The study coordinating centre is at the
University of Alberta. Case report forms and data monitoring will be completed
electronically, using an online EDC system. All imaging data will be read centrally at the
Stroke Imaging Laboratory at the University of Alberta.
Study Design Considerations:
A randomized controlled design was considered (dabigatran versus warfarin). This is
considered impractical for a number of reasons. Novel oral anticoagulants are recommended as
first line agents for stroke prevention in AF patients by the Canadian Cardiovascular
Society.19 These agents are associated with improved safety with respect to bleeding
complications. This makes randomization of a patient to warfarin who would otherwise be
prescribed dabigatran somewhat ethically dubious. In addition, a randomized design would
necessitate a very large study, which would not be completed in a reasonable period of time.
A registry design allows us to address the question of safety in a systematic fashion. A
safety threshold has been defined for any anticoagulant use early after stroke, based on the
rates of warfarin-associated intracranial hemorrhage, which have been reported to be 0.5 to
2.5 per 100 patient years.20-24 The registry design therefore permits determination of
whether or not dabigatran is within this threshold. Finally, the systematic collection of
clinical and imaging data will allow us to determine any risk factors for hemorrhagic
transformation associated with early anticoagulation.
Prescribed Study Treatments:
Patients in whom dabigatran is initiated within 14 days of TIA/stroke symptom onset will be
included in the registry. Patients will be treated either at a dose of 110 mg BID or 150 mg
BID. The dose and timing of initiation of therapy within that 14 day window will be
determined by the treating physician. The factors related to physician choice of initiation
time (relative to symptom onset) will be recorded.
Visit Schedule / Clinical Data Collection:
Standard clinical assessments and data will be collected. This will include baseline National
Institutes of Health Stroke Scale NIHSS, Glasgow Coma Scale (GCS) and vital signs, which will
be recorded in a case report form. Stroke risk factors, past medical history and medications,
baseline complete blood count, coagulation profile and renal function tests will also be
recorded. CHADS2 and CHADSVaSC scores will also be recorded. Clinical endpoints will be
ischemic stroke or intracranial hemorrhage within 30 days of anticoagulant initiation. All
cerebral ischemic and intracranial hemorrhagic endpoints will be centrally adjudicated from
anonymized clinical records, with the intracranial hemorrhages classified as described above.
A data collection form will be filled out for each subject at 30 days post-enrolment
indicating clinical status and occurrence of outcome events.
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