Comparison · NCT04688320-bd8a1f6b
Recombinant Nonimmunogenic Staphylokinase vs Alteplase: Death From PE
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. Recombinant Nonimmunogenic Staphylokinase vs Alteplase: Death From PE. Trial comparisons, record NCT04688320-bd8a1f6b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04688320-bd8a1f6b
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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 | 0.0276 | 0.0108 | 0.0688 | wilson | |
| Risk in group 2 | 0.0137 | 0.00376 | 0.0486 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0139 | -0.0248 | 0.0563 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.01 | 0.375 | 10.8 | log | |
| Odds ratio, group 1 over group 2 | 2.04 | 0.368 | 11.3 | log | |
| Number needed to treat, for one more participant with the outcome on Recombinant Nonimmunogenic Staphylokinase than on Alteplase | 72 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Recombinant Nonimmunogenic Staphylokinase | lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight.~Recombinant nonimmunogenic staphylokinase: 15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds | 4 | 145 | OG000 |
| Group 2 | Alteplase | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.~Alteplase: Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. | 2 | 146 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Death From PE
- Description
- The efficacy is evaluated in terms of the number of deaths from PE
- Time frame
- within 30 days
- Population
- The efficacy is evaluated in terms of the number of deaths from PE in the per-protocol population
Source ClinicalTrials.gov
Trial
- Title
- Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
- NCT number
- NCT04688320
- Phases
- PHASE3
- Conditions
- Massive Pulmonary Embolism
- Interventions
- Recombinant nonimmunogenic staphylokinase, Alteplase
- Lead sponsor
- Supergene, LLC
- Results first posted
- 2025-04-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04688320?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.
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