Canadian Pradaxa Acute Stroke Safety Study (CPASS)
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|ClinicalTrials.gov Identifier: NCT02415855|
Recruitment Status : Completed
First Posted : April 14, 2015
Last Update Posted : May 25, 2018
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.
- Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients with atrial fibrillation.
- Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of dabigatran treatment following stroke/TIA
- Determine the effect of asymptomatic hemorrhagic transformation on functional and neurological outcome at 30 days.
|Condition or disease||Intervention/treatment|
|Ischemic Attack, Transient Stroke||Drug: Dabigatran|
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.
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.
|Study Type :||Observational [Patient Registry]|
|Actual Enrollment :||100 participants|
|Target Follow-Up Duration:||30 Days|
|Official Title:||Canadian Pradaxa Acute Stroke Safety Study|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||March 31, 2018|
|Actual Study Completion Date :||May 18, 2018|
- Drug: Dabigatran
Other Name: Pradaxa
- Symptomatic Hemorrhagic Transformation Rate (PH2) [ Time Frame: 30 days post-treatment ]Symptomatic Hemorrhagic Transformation Rate (PH2) associated with clinical deterioration, defined as worsening of NIHSS score of 4 or more points within 30 days of initiating dabigatran therapy.
- Any parenchymal haemorrhage (PH1 or PH2) [ Time Frame: 7 days post-enrollemnt ]Any parenchymal haemorrhage (PH1 or PH2) on follow-up CT scan at 7±2 days post-enrolment.
- Symptomatic hemorrhagic transformation rate [ Time Frame: 30 days post enrolment ]Symptomatic hemorrhagic transformation rate (defined as above) in patients treated with warfarin prior to the index stroke/TIA.
- Recurrent TIA/Ischemic Stroke [ Time Frame: 30 days post enrolment ]
- Systemic hemorrhagic complication rate [ Time Frame: 30 days post enrolment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02415855
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2B7|
|Ottawa Hospital Research Institute|
|Ottawa, Ontario, Canada, K1Y 4E9|