Trial Outcomes & Findings for Canadian Pradaxa Acute Stroke Safety Study (NCT NCT02415855)

NCT ID: NCT02415855

Last Updated: 2020-06-19

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 101 participants
• Primary outcome timeframe: 30 days post-treatment
• Results posted on: 2020-06-19

Participant Flow

Participants were approached after the treating physician's decision to treat with dabigatran within 14 days of stroke/TIA, independent of the registry.

Participant milestones

Measure	Dabigatran 110 mg BID Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Overall Study STARTED	37	64
Overall Study COMPLETED	34	62
Overall Study NOT COMPLETED	3	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Dabigatran 110 mg BID n=37 Participants Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 Participants Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.	Total n=101 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=37 Participants	0 Participants n=64 Participants	0 Participants n=101 Participants
Age, Categorical Between 18 and 65 years	18 Participants n=37 Participants	30 Participants n=64 Participants	48 Participants n=101 Participants
Age, Categorical >=65 years	19 Participants n=37 Participants	34 Participants n=64 Participants	53 Participants n=101 Participants
Age, Continuous	72 years n=37 Participants	72 years n=64 Participants	72 years n=101 Participants
Sex: Female, Male Female	13 Participants n=37 Participants	22 Participants n=64 Participants	35 Participants n=101 Participants
Sex: Female, Male Male	24 Participants n=37 Participants	42 Participants n=64 Participants	66 Participants n=101 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	37 Participants n=37 Participants	64 Participants n=64 Participants	101 Participants n=101 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Dabigatran 110 mg BID n=37 Participants Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 Participants Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Symptomatic Hemorrhagic Transformation Rate (PH2)	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 7 days post-enrollment

Any parenchymal haemorrhage (PH1 or PH2) on follow-up CT scan at 7±2 days post-enrolment.

Outcome measures

Measure	Dabigatran 110 mg BID n=37 Participants Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 Participants Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Any Parenchymal Haemorrhage (PH1 or PH2)	3 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days post enrolment

Symptomatic hemorrhagic transformation rate (defined as above) in patients treated with warfarin prior to the index stroke/TIA.

Outcome measures

Measure	Dabigatran 110 mg BID n=37 Participants Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 Participants Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Symptomatic Hemorrhagic Transformation Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 30 days post enrolment

Monitoring and documentation of recurrent TIAs or Ischemic Stroke occuring in participants of both arms

Outcome measures

Measure	Dabigatran 110 mg BID n=37 Participants Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 Participants Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Recurrent TIA/Ischemic Stroke	2 Participants	2 Participants

SECONDARY outcome

Timeframe: 30 days post enrolment

Monitoring and documentation of the number of the rate of hemorrhagic complications for participants in either arm of the study.

Outcome measures

Measure	Dabigatran 110 mg BID n=37 Participants Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 Participants Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Systemic Hemorrhagic Complication Rate	0 Participants	0 Participants

Adverse Events

Dabigatran 110 mg BID

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Dabigatran 150mg BID

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Dabigatran 110 mg BID n=37 participants at risk Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 participants at risk Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Nervous system disorders Recurrent Stroke	2.7% 1/37 • Number of events 1 • 30 days from start of medication.	0.00% 0/64 • 30 days from start of medication.

Other adverse events

Measure	Dabigatran 110 mg BID n=37 participants at risk Participants with an estimated glomerular filtration rate 30-50 ml/min and/or age 80 years received Dabigatran 110 mg twice a day.	Dabigatran 150mg BID n=64 participants at risk Participants who were under 80 yrs of age and who had an estimated glomerular filtration rate of greater than 50 ml/min were treated with dabigatran 150mg BID.
Endocrine disorders Bleeding per rectum	2.7% 1/37 • Number of events 1 • 30 days from start of medication.	0.00% 0/64 • 30 days from start of medication.
Nervous system disorders Sensory loss/Paresthesias, weak arms and headaches	0.00% 0/37 • 30 days from start of medication.	1.6% 1/64 • Number of events 1 • 30 days from start of medication.

Additional Information

Dr. Kenneth Butcher

University of Alberta

Phone: 780-407-4366

Email: ken.butcher@ualberta.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place