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Canadian Pradaxa Acute Stroke Safety Study

NCT02415855 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 101

Last updated 2020-06-19

Study results available
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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.

Conditions

  • Ischemic Attack, Transient
  • Stroke

Interventions

DRUG

Dabigatran

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2018-03-31
Completion
2018-05-18

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02415855 on ClinicalTrials.gov