Canadian Pradaxa Acute Stroke Safety Study

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Collaborator: Boehringer Ingelheim
• Treatments: Dabigatran

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.