Comparison · NCT02398656-sae
Tenecteplase (tNK) vs Control (Antiplatelet Agents): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Tenecteplase (tNK) vs Control (Antiplatelet Agents): serious adverse events. Trial comparisons, record NCT02398656-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02398656-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.037 | 0.0229 | 0.0593 | wilson | |
| Risk in group 2 | 0.00442 | 0.00121 | 0.016 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0326 | 0.0144 | 0.0551 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 8.37 | 1.94 | 36.2 | log | |
| Odds ratio, group 1 over group 2 | 8.65 | 1.98 | 37.9 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Tenecteplase (tNK) than on Control (Antiplatelet Agents) | 30.7 | 18.1 | 69.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: control.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tenecteplase (tNK) | Experimental: TNK-tPA (0.25mg/kg) given as a single, intravenous bolus immediately upon randomization. Experimental treatment will be administered as a single intravenous bolus over 1-2 minutes as per the standard manufacturers' instructions for use. Tenecteplase, a genetically engineered mutant tissue plasminogen activator, has a longer half-life, is more fibrin specific, produces less systemic depletion of circulating fibrinogen, and is more resistant to plasminogen activator inhibitor than alteplase.~Tenecteplase: TNK will be administered as a single intravenous bolus over 1-2 minutes within 90 minutes of the CT scan. | 16 | 432 | EG000 |
| Group 2 | Control (Antiplatelet Agents) | Control: Patients will be treated with standard of care based antiplatelet treatment - choice at the discretion of the investigator. Low dose aspirin (single agent) will be the choice of most physicians, some will chose to use the combination of aspirin and clopidogrel. As this is a multi-centre, international trial where local practices will vary, rather than mandating a specific antiplatelet agent, we will allow the local investigator to chose which antithrombotic regime should be used. Standard of care medication(s) should be given immediately upon randomization.~Antiplatelet treatment: Low dose aspirin (single agent) will be the choice of most physicians, some Investigators will chose to use the combination of aspirin and clopidogrel. | 2 | 452 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse events were collected from randomization to Day 5 or discharge ( whichever was sooner). SAE's were collected to the Day 90 assessment completion. AEs and SAE's were collected from the beginning of the trial until the last Day 90 assessment was completed.
Source ClinicalTrials.gov
Trial
- Title
- A Randomized Controlled Trial of TNK-tPA Versus Standard of Care for Minor Ischemic Stroke With Proven Occlusion
- NCT number
- NCT02398656
- Phases
- PHASE3
- Conditions
- Stroke, Acute
- Interventions
- Tenecteplase, Antiplatelet treatment
- Lead sponsor
- University of Calgary
- Results first posted
- 2025-01-31
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02398656?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT02398656-sae