Trial · NCT02398656
A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion
NCT02398656, Phase 3, Completed, University of Calgary; results first posted 2025-01-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion. Trials, record NCT02398656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02398656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion
- NCT number
- NCT02398656
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,274 participants, actual
- Lead sponsor
- University of Calgary
- Conditions
- Stroke, Acute
- Interventions
- Tenecteplase, Antiplatelet treatment
- First posted
- 2015-03-25
- Last updated
- 2025-01-31
- Results first posted
- 2025-01-31
- Limitations and caveats
- The trial was ended based on a recommendation from the DSMB that to continue was futile.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS) | 90 Days | Analysis will be a responder analysis where return to baseline level of neurological functioning is defined as follows: If pre-morbid mRS is 0-1 then mRS 0-1 at 90 days is a good outcome. If pre-morbid mRS is 2 then mRS 0-2 is a good outcome. Pre-morbid mRS is assessed using the structured mRS prior to randomization. Outcomes at 90 days will be assessed by an individual blinded to the treatment assignment. The 90day mRS will be rated using the structured mRS questionnaire . The 90 day mRS will be completed in person where possible and by telephone otherwise. The structured questionnaire has been showed to improve reliability in assessing the mRS both in person and by telephone. This is a scale from 0-6. Higher scores mean a worse outcome. |
| Secondary | Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days | 90 days | Pre-morbid mRS is assessed using the structured mRS prior to randomization. Outcomes will be assessed by an individual blinded to the treatment assignment. The 90day mRS will be rated using the structured mRS questionnaire . The 90 day mRS will be completed in person where possible and by telephone otherwise. The structured questionnaire has been showed to improve reliability in assessing the mRS both in person and by telephone. This is a scale from 0-6. Higher scores mean a worse outcome. mRS 0-1 represents excellent functional outcome. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS) | 90 Days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days | 90 days | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS) | Tenecteplase (tNK) | 309 | Participants | ||
| Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS) | Control (Antiplatelet Agents) | 338 | Participants | ||
| Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days | Tenecteplase (tNK) | 298 | Participants | ||
| Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days | Control (Antiplatelet Agents) | 321 | 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 | Tenecteplase (tNK) | 637 | |
| Overall Study | STARTED | Control (Antiplatelet Agents) | 637 | |
| Overall Study | COMPLETED | Tenecteplase (tNK) | 454 | |
| Overall Study | COMPLETED | Control (Antiplatelet Agents) | 432 | |
| Overall Study | NOT COMPLETED | Tenecteplase (tNK) | 183 | |
| Overall Study | NOT COMPLETED | Control (Antiplatelet Agents) | 205 |
Source ClinicalTrials.gov
Adverse events4
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 | Stroke Progression | Nervous system disorders | Tenecteplase (tNK) | 35 | 435 | 35 |
| other | Stroke Progression | Nervous system disorders | Control (Antiplatelet Agents) | 33 | 452 | 33 |
| serious | Symptomatic Intracerebral hemorrhage | Nervous system disorders | Tenecteplase (tNK) | 16 | 432 | 16 |
| serious | Symptomatic Intracerebral hemorrhage | Nervous system disorders | Control (Antiplatelet Agents) | 2 | 452 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenecteplase (tNK) | 20 | 425 |
| Total, all-cause mortality | Control (Antiplatelet Agents) | 5 | 442 |
| Total, other adverse events | Tenecteplase (tNK) | 35 | 435 |
| Total, other adverse events | Control (Antiplatelet Agents) | 33 | 452 |
| Total, serious adverse events | Tenecteplase (tNK) | 16 | 432 |
| Total, serious adverse events | Control (Antiplatelet Agents) | 2 | 452 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Tenecteplase (tNK) vs Control (Antiplatelet Agents): Number of Participants With Return to Baseline Neurological Functioning Measured by the Modified Rankin Scale (mRS) | Trial comparisons |
| Tenecteplase (tNK) vs Control (Antiplatelet Agents): Number of Participants With Modified Rankin Score (mRS) 0-1 at 90 Days | Trial comparisons |
| Tenecteplase (tNK) vs Control (Antiplatelet Agents): deaths from any cause | Trial comparisons |
| Tenecteplase (tNK) vs Control (Antiplatelet Agents): 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/NCT02398656
GET https://conductscience.org/api/trials/v1/NCT02398656/registered