Trial · NCT02415855
Canadian Pradaxa Acute Stroke Safety Study
NCT02415855, Completed, University of Alberta; results first posted 2020-06-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Canadian Pradaxa Acute Stroke Safety Study. Trials, record NCT02415855. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02415855
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Canadian Pradaxa Acute Stroke Safety Study
- NCT number
- NCT02415855
- Status
- Completed
- Enrollment
- 101 participants, actual
- Lead sponsor
- University of Alberta
- Conditions
- Ischemic Attack, Transient, Stroke
- Interventions
- Dabigatran
- First posted
- 2015-04-14
- Last updated
- 2020-06-19
- Results first posted
- 2020-06-19
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Symptomatic Hemorrhagic Transformation Rate (PH2) | 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. |
| Secondary | Any Parenchymal Haemorrhage (PH1 or PH2) | 7 days post-enrollment | Any parenchymal haemorrhage (PH1 or PH2) on follow-up CT scan at 7±2 days post-enrolment. |
| Secondary | Symptomatic Hemorrhagic Transformation Rate | 30 days post enrolment | Symptomatic hemorrhagic transformation rate (defined as above) in patients treated with warfarin prior to the index stroke/TIA. |
| Secondary | Recurrent TIA/Ischemic Stroke | 30 days post enrolment | Monitoring and documentation of recurrent TIAs or Ischemic Stroke occuring in participants of both arms |
| Secondary | Systemic Hemorrhagic Complication Rate | 30 days post enrolment | Monitoring and documentation of the number of the rate of hemorrhagic complications for participants in either arm of the study. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Symptomatic Hemorrhagic Transformation Rate (PH2) | 30 days post-treatment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Any Parenchymal Haemorrhage (PH1 or PH2) | 7 days post-enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Symptomatic Hemorrhagic Transformation Rate | 30 days post enrolment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Recurrent TIA/Ischemic Stroke | 30 days post enrolment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Systemic Hemorrhagic Complication Rate | 30 days post enrolment | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Symptomatic Hemorrhagic Transformation Rate (PH2) | Dabigatran 110 mg BID | 0 | Participants | ||
| Symptomatic Hemorrhagic Transformation Rate (PH2) | Dabigatran 150mg BID | 0 | Participants | ||
| Any Parenchymal Haemorrhage (PH1 or PH2) | Dabigatran 110 mg BID | 3 | Participants | ||
| Any Parenchymal Haemorrhage (PH1 or PH2) | Dabigatran 150mg BID | 3 | Participants | ||
| Symptomatic Hemorrhagic Transformation Rate | Dabigatran 110 mg BID | 0 | Participants | ||
| Symptomatic Hemorrhagic Transformation Rate | Dabigatran 150mg BID | 0 | Participants | ||
| Recurrent TIA/Ischemic Stroke | Dabigatran 110 mg BID | 2 | Participants | ||
| Recurrent TIA/Ischemic Stroke | Dabigatran 150mg BID | 2 | Participants | ||
| Systemic Hemorrhagic Complication Rate | Dabigatran 110 mg BID | 0 | Participants | ||
| Systemic Hemorrhagic Complication Rate | Dabigatran 150mg BID | 0 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Dabigatran 110 mg BID | 37 | |
| Overall Study | STARTED | Dabigatran 150mg BID | 64 | |
| Overall Study | COMPLETED | Dabigatran 110 mg BID | 34 | |
| Overall Study | COMPLETED | Dabigatran 150mg BID | 62 | |
| Overall Study | NOT COMPLETED | Dabigatran 110 mg BID | 3 | |
| Overall Study | NOT COMPLETED | Dabigatran 150mg BID | 2 |
Source ClinicalTrials.gov
Adverse events6
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bleeding per rectum | Endocrine disorders | Dabigatran 110 mg BID | 1 | 37 | 1 |
| other | Bleeding per rectum | Endocrine disorders | Dabigatran 150mg BID | 0 | 64 | 0 |
| other | Sensory loss/Paresthesias, weak arms and headaches | Nervous system disorders | Dabigatran 110 mg BID | 0 | 37 | 0 |
| other | Sensory loss/Paresthesias, weak arms and headaches | Nervous system disorders | Dabigatran 150mg BID | 1 | 64 | 1 |
| serious | Recurrent Stroke | Nervous system disorders | Dabigatran 110 mg BID | 1 | 37 | 1 |
| serious | Recurrent Stroke | Nervous system disorders | Dabigatran 150mg BID | 0 | 64 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dabigatran 110 mg BID | 1 | 37 |
| Total, all-cause mortality | Dabigatran 150mg BID | 0 | 64 |
| Total, other adverse events | Dabigatran 110 mg BID | 1 | 37 |
| Total, other adverse events | Dabigatran 150mg BID | 1 | 64 |
| Total, serious adverse events | Dabigatran 110 mg BID | 1 | 37 |
| Total, serious adverse events | Dabigatran 150mg BID | 0 | 64 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: Any Parenchymal Haemorrhage (PH1 or PH2) | Trial comparisons |
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: Symptomatic Hemorrhagic Transformation Rate (PH2) | Trial comparisons |
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: Symptomatic Hemorrhagic Transformation Rate | Trial comparisons |
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: Systemic Hemorrhagic Complication Rate | Trial comparisons |
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: deaths from any cause | Trial comparisons |
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: Recurrent TIA/Ischemic Stroke | Trial comparisons |
| Dabigatran 110 mg BID vs Dabigatran 150mg BID: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02415855
GET https://conductscience.org/api/trials/v1/NCT02415855/registered