Canadian Pradaxa Acute Stroke Safety Study

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02415855
• Date of registration: 09/04/2015
• Prospective Registration: No
• Primary sponsor: University of Alberta
• Public title: Canadian Pradaxa Acute Stroke Safety Study CPASS
• Scientific title: Canadian Pradaxa Acute Stroke Safety Study
• Date of first enrolment: March 2015
• Target sample size: 101
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02415855
• Study type: Observational [Patient Registry]

Countries of recruitment

Canada

Key inclusion & exclusion criteria

Inclusion Criteria:

1. All patients will be = 18 years of age.

2. Minor ischemic stroke, defined as NIHSS score = 3. Transient Ischemic Attack (TIA),
defined as acute focal neurological deficits, with complete resolution of symptoms
within 24 h of onset. In cases where onset time cannot be established, it will be
considered to be the time when the patient was last known to be well.

3. Atrial Fibrillation (AF, paroxysmal or persistent). AF must be confirmed with
ECG/Holter monitor, or by history All patients prescribed dabigatran according to the
Canadian product label by the treating physician following their stroke/TIA. The
decision to treat with dabigatran and the timing of the first dose will be determined
by the attending physician, independent of the registry. All patients will have a CT
scan or MRI, with findings consistent with an ischemic etiology of symptoms.

4. Ability to obtain informed consent obtained from patient or legally authorized
representative.

Exclusion Criteria:

1. Acute or chronic renal failure, defined as eGFR <30 ml/min (Cockcroft Gault formula).

2. Known hypersensitivity to dabigatran or any other contraindication to dabigatran
therapy, as per Canadian label information.

3. Prior treatment with dabigatran or any other novel oral anticoagulant (including all
Factor Xa antagonists). Treatment with warfarin prior to the stroke/TIA is acceptable,
but enrolment cannot begin until the INR is =1.5.

4. Prior symptomatic ischemic stroke (TIA is not an exclusion criterion)

5. Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent
major surgery.

6. Clinically significant recent past history or clinical presentation of ICH,
subarachnoid haemorrhage (SAH), arterio-venous (AV) malformation, aneurysm, or
cerebral neoplasm. At the discretion of each Investigator.

7. Hereditary or acquired hemorrhagic diathesis.

8. Anticipated inability to comply with follow up.

9. Any condition that, in the judgment of the investigator could impose hazards to the
patient if study therapy is initiated or affect the participation of the patient in
the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Stroke

Ischemic Attack, Transient

Intervention(s)

Drug: Dabigatran

Primary Outcome(s)

Symptomatic Hemorrhagic Transformation Rate (PH2) [Time Frame: 30 days post-treatment]

Secondary Outcome(s)

Systemic Hemorrhagic Complication Rate [Time Frame: 30 days post enrolment]

Any Parenchymal Haemorrhage (PH1 or PH2) [Time Frame: 7 days post-enrollment]

Recurrent TIA/Ischemic Stroke [Time Frame: 30 days post enrolment]

Symptomatic Hemorrhagic Transformation Rate [Time Frame: 30 days post enrolment]

Secondary ID(s)

CSC2012-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim

Results

• Results available: Yes
• Date Posted: 19/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02415855