Trial · NCT01654445
TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion
NCT01654445, Phase 2, Completed, University of Calgary; results first posted 2020-11-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion. Trials, record NCT01654445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01654445
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- TNK-tPA Evaluation for Minor Ischemic Stroke With Proven Occlusion
- NCT number
- NCT01654445
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- University of Calgary
- Conditions
- Ischemic Stroke
- Interventions
- Tenecteplase
- First posted
- 2012-07-31
- Last updated
- 2020-11-25
- Results first posted
- 2020-11-25
- Limitations and caveats
TEMPO-1 was a phase 2 study with a limited sample size. The program was designed to assess feasibility and safety and not efficacy. A further larger phase 3 study is planned.~Only selected adverse events are presented here. All SAEs are reported.
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Serious Bleeding Events | Up to 12 weeks | The primary safety outcome will be the rate of expected serious adverse events associated with study drug. This will be defined as the number patients with at least one SAE divided by the number of patients enrolled by dose-tier. Thus, the unit of analysis will be the patient and not the SAE. |
| Secondary | Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | 90 days | Complete neurological and functional recovery at 90 days defined as: NIHSS 0 and mRS 0 iii)Complete neurological and functional recovery at 90 days defined as: a. NIHSS 0-1 and mRS 0-1 and Barthel Index \> 90 NIHSS = National Institutes of Health Stroke Scale. This integer scale ranges 0-42 and is a quantitative measure of the neurological examination. mRS = modified Rankin Scale. This integer scale ranges from 0-6 and is a criterion-based quantitative measure of functional neurological disability. BI = Barthel Index. This scale range from 0-100 (in increments of 5 points) and is a summative categorical score measuring activities of daily living. |
| Other | Number of Patients With Recanalization 4-8 Hours Post-treatment | 4-8 hours | Recanalization defined on follow-up 4-8 hour CTA as a modified arterial occlusive lesion (mAOL) score 0-1. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Serious Bleeding Events | Up to 12 weeks | All participants | Participants | NUMBER |
| SECONDARY | Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | 90 days | All enrolled participants | Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Patients With Recanalization 4-8 Hours Post-treatment | 4-8 hours | 2 patients in each tier had missing data on this outcome. | Participants | NUMBER |
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 |
|---|---|---|---|---|---|
| Number of Patients With Serious Bleeding Events | Tenecteplase 0.1 mg/kg | 0 | Participants | ||
| Number of Patients With Serious Bleeding Events | Tenecteplase 0.25 mg/kg | 1 | Participants | ||
| Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | Tenecteplase 0.1 mg/kg | NIHSS = 0 at 90d | 15 | Participants | |
| Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | Tenecteplase 0.25 mg/kg | NIHSS = 0 at 90d | 19 | Participants | |
| Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | Tenecteplase 0.1 mg/kg | mRS = 0 at 90d | 10 | Participants | |
| Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | Tenecteplase 0.25 mg/kg | mRS = 0 at 90d | 14 | Participants | |
| Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | Tenecteplase 0.1 mg/kg | Barthel Index > 90 at 90d | 22 | Participants | |
| Number of Patients With NIHSS 0 and mRS 0 and Barthel Index > 90 | Tenecteplase 0.25 mg/kg | Barthel Index > 90 at 90d | 22 | Participants | |
| Number of Patients With Recanalization 4-8 Hours Post-treatment | Tenecteplase 0.1 mg/kg | 9 | Participants | ||
| Number of Patients With Recanalization 4-8 Hours Post-treatment | Tenecteplase 0.25 mg/kg | 12 | 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 0.1 mg/kg | 25 | |
| Overall Study | STARTED | Tenecteplase 0.25 mg/kg | 25 | |
| Overall Study | COMPLETED | Tenecteplase 0.1 mg/kg | 25 | |
| Overall Study | COMPLETED | Tenecteplase 0.25 mg/kg | 25 | |
| Overall Study | NOT COMPLETED | Tenecteplase 0.1 mg/kg | 0 | |
| Overall Study | NOT COMPLETED | Tenecteplase 0.25 mg/kg | 0 |
Source ClinicalTrials.gov
Adverse events14
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 | Asymptomatic intracerebral hemorrhage | Nervous system disorders | Tenecteplase 0.1 mg/kg | 1 | 25 | 1 |
| other | Asymptomatic intracerebral hemorrhage | Nervous system disorders | Tenecteplase 0.25 mg/kg | 1 | 25 | |
| other | Atrial fibrillation | Cardiac disorders | Tenecteplase 0.1 mg/kg | 3 | 25 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Tenecteplase 0.25 mg/kg | 0 | 25 | 0 |
| other | Headache | Nervous system disorders | Tenecteplase 0.1 mg/kg | 5 | 25 | 5 |
| other | Headache | Nervous system disorders | Tenecteplase 0.25 mg/kg | 3 | 25 | 3 |
| other | Carotid revascluarization (CEA or CAS) | Vascular disorders | Tenecteplase 0.1 mg/kg | 2 | 25 | 2 |
| other | Carotid revascluarization (CEA or CAS) | Vascular disorders | Tenecteplase 0.25 mg/kg | 0 | 25 | 0 |
| other | Urinary tract infection | Renal and urinary disorders | Tenecteplase 0.1 mg/kg | 1 | 25 | 1 |
| other | Urinary tract infection | Renal and urinary disorders | Tenecteplase 0.25 mg/kg | 2 | 25 | 2 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tenecteplase 0.1 mg/kg | 0 | 25 |
| Total, all-cause mortality | Tenecteplase 0.25 mg/kg | 1 | 25 |
| Total, other adverse events | Tenecteplase 0.1 mg/kg | 12 | 25 |
| Total, other adverse events | Tenecteplase 0.25 mg/kg | 8 | 25 |
| Total, serious adverse events | Tenecteplase 0.1 mg/kg | 0 | 25 |
| Total, serious adverse events | Tenecteplase 0.25 mg/kg | 1 | 25 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25677596 | RESULT |
Source PubMed
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 0.1 mg/kg vs Tenecteplase 0.25 mg/kg: Number of Patients With Serious Bleeding Events | Trial comparisons |
| Tenecteplase 0.1 mg/kg vs Tenecteplase 0.25 mg/kg: Number of Patients With Recanalization 4-8 Hours Post-treatment | Trial comparisons |
| Tenecteplase 0.1 mg/kg vs Tenecteplase 0.25 mg/kg: deaths from any cause | Trial comparisons |
| Tenecteplase 0.1 mg/kg vs Tenecteplase 0.25 mg/kg: 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/NCT01654445
GET https://conductscience.org/api/trials/v1/NCT01654445/registered