Canadian Pradaxa Acute Stroke Safety Study

NCT02415855 | Completed Results DMC

• 1 other identifier: CSC2012-01
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 2

Brief 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. 1.Demonstrate the safety of early dabigatran initiation after minor stroke/TIA in patients with atrial fibrillation.
2. 2.Determine the frequency of asymptomatic hemorrhagic transformation after 7 days of dabigatran treatment following stroke/TIA
3. 3.Determine the effect of asymptomatic hemorrhagic transformation on functional and neurological outcome at 30 days.

Conditions

Ischemic Attack, Transient; Stroke

Outcome Measures

Primary Outcomes (1)

• Symptomatic Hemorrhagic Transformation Rate (PH2)

  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.

  30 days post-treatment

Secondary Outcomes (4)

• Any Parenchymal Haemorrhage (PH1 or PH2)

  7 days post-enrollment

• Symptomatic Hemorrhagic Transformation Rate

  30 days post enrolment

• Recurrent TIA/Ischemic Stroke

  30 days post enrolment

• Systemic Hemorrhagic Complication Rate

  30 days post enrolment

Interventions

Dabigatran DRUG

Also known as: Pradaxa

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Minor Stroke (NIHSS Score ≤ 3) and Transient Ischemic Attack Patients ≥ 18 years of age, with a known history of or demonstrated atrial fibrillation (paroxysmal or persistent), who can be treated with dabigatran following stroke.

You may qualify if:

• All patients will be ≥ 18 years of age.
• 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.
• 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.
• Ability to obtain informed consent obtained from patient or legally authorized representative.

You may not qualify if:

• Acute or chronic renal failure, defined as eGFR \<30 ml/min (Cockcroft Gault formula).
• Known hypersensitivity to dabigatran or any other contraindication to dabigatran therapy, as per Canadian label information.
• 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.
• Any significant ongoing systemic bleeding risk, i.e. active GI/GU bleeding or recent major surgery.
• 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.
• Hereditary or acquired hemorrhagic diathesis.
• Anticipated inability to comply with follow up.
• 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.

Sponsors & Collaborators

• University of Alberta: lead
• Boehringer Ingelheim: collaborator

Study Sites (2)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Ischemic Attack, Transient; Stroke

Interventions

Dabigatran

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Kenneth Butcher
• Organization: University of Alberta

ken.butcher@ualberta.ca

780-407-4366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2015
• First Posted: April 14, 2015
• Study Start: March 1, 2015
• Primary Completion: March 31, 2018
• Study Completion: May 18, 2018
• Last Updated: June 19, 2020
• Results First Posted: June 19, 2020

Record last verified: 2020-06

Locations

CA (2)