Trial · NCT04688320

Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE

NCT04688320, Phase 3, Completed, Supergene, LLC; results first posted 2025-04-02

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE. Trials, record NCT04688320. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04688320

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
NCT number: NCT04688320
Status: Completed
Phases: Phase 3
Enrollment: 310 participants, actual
Lead sponsor: Supergene, LLC
Conditions: Massive Pulmonary Embolism
Interventions: Recombinant nonimmunogenic staphylokinase, Alteplase
First posted: 2020-12-29
Last updated: 2025-04-02
Results first posted: 2025-04-02

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Death From All Causes	within 7 days	The efficacy is evaluated in terms of the number of deaths from all causes
Secondary	Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	baseline and day 1, 7, 14 after randomisation	The efficacy is evaluated in terms of systolic pulmonary artery pressure values
Secondary	Haemodynamic Collapse	within 7 days	The efficacy is evaluated in terms of the number of haemodynamic collapse
Secondary	Recurrent Pulmonary Embolism (PE)	within 7 days	The efficacy is evaluated in terms of the number of recurrent PE
Secondary	Death From PE	within 30 days	The efficacy is evaluated in terms of the number of deaths from PE
Secondary	Death From All Causes	within 30 days	The efficacy is evaluated in terms of the number of deaths from all causes
Secondary	Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days	within 30 days	The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes
Secondary	Safety Endpoint - Haemorrhagic Stroke	within 7 days	The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation
Secondary	Safety Endpoint - BARC Type 3+5 Bleeding	within 30 days	The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding. Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents. Type 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision. Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious. Type 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation.
Secondary	Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)	within 30 days	The safety is evaluated in terms of the number and severity of serious adverse events (SAEs)

Source ClinicalTrials.gov

Outcomes10

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Death From All Causes	within 7 days	in the per-protocol population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	baseline and day 1, 7, 14 after randomisation	The efficacy is evaluated in terms of decreasing of pulmonary artery systolic pressure (PASP) values on baseline and day 1, 7, 14 after randomisation in the per-protocol population	mm Hg	MEDIAN
SECONDARY	Haemodynamic Collapse	within 7 days	The efficacy is evaluated in terms of the number of haemodynamic collapse in the per-protocol population	events	NUMBER
SECONDARY	Recurrent Pulmonary Embolism (PE)	within 7 days	The efficacy is evaluated in terms of the number of recurrent PE in the per-protocol population	events	NUMBER
SECONDARY	Death From PE	within 30 days	The efficacy is evaluated in terms of the number of deaths from PE in the per-protocol population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Death From All Causes	within 30 days	The efficacy is evaluated in terms of the number of deaths from all causes in the per-protocol population	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days	within 30 days	The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes within 30 days in the per-protocol population	events	NUMBER
SECONDARY	Safety Endpoint - Haemorrhagic Stroke	within 7 days	The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation in the per-protocol population	events	NUMBER
SECONDARY	Safety Endpoint - BARC Type 3+5 Bleeding	within 30 days	The safety is evaluated in terms of the number of BARC type 3+5 bleeding within 30 days in the per-protocol population	events	NUMBER
SECONDARY	Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)	within 30 days	The safety is evaluated in terms of the number and severity of serious adverse events (SAEs) in the per-protocol population	events	NUMBER

Source ClinicalTrials.gov

Results by group26

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Death From All Causes	Recombinant Nonimmunogenic Staphylokinase		3		Participants
Death From All Causes	Alteplase		4		Participants
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Recombinant Nonimmunogenic Staphylokinase	PASP on baseline	59	Inter-Quartile Range 50 to 69	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Alteplase	PASP on baseline	58	Inter-Quartile Range 51 to 69	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Recombinant Nonimmunogenic Staphylokinase	PASP on day 1	44	Inter-Quartile Range 36 to 52	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Alteplase	PASP on day 1	42	Inter-Quartile Range 36 to 50	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Recombinant Nonimmunogenic Staphylokinase	PASP on day 7	36	Inter-Quartile Range 31 to 44	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Alteplase	PASP on day 7	35	Inter-Quartile Range 29 to 41	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Recombinant Nonimmunogenic Staphylokinase	PASP on day 14	35	Inter-Quartile Range 30 to 41	mm Hg
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)	Alteplase	PASP on day 14	35	Inter-Quartile Range 28 to 41	mm Hg

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Recombinant Nonimmunogenic Staphylokinase	155
Overall Study	STARTED	Alteplase	155
Overall Study	COMPLETED	Recombinant Nonimmunogenic Staphylokinase	145
Overall Study	COMPLETED	Alteplase	146
Overall Study	NOT COMPLETED	Recombinant Nonimmunogenic Staphylokinase	10
Overall Study	NOT COMPLETED	Alteplase	9

Source ClinicalTrials.gov

Adverse events20

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	Hematuria	Blood and lymphatic system disorders	Recombinant Nonimmunogenic Staphylokinase	72	155	72
other	Hematuria	Blood and lymphatic system disorders	Alteplase	86	155	86
serious	Recurrent PE	Cardiac disorders	Recombinant Nonimmunogenic Staphylokinase	1	145	1
serious	Recurrent PE	Cardiac disorders	Alteplase	2	146	2
serious	Haemodynamic collapse	Cardiac disorders	Recombinant Nonimmunogenic Staphylokinase	1	145	1
serious	Haemodynamic collapse	Cardiac disorders	Alteplase	3	146	3
serious	Ischaemic stroke	Nervous system disorders	Recombinant Nonimmunogenic Staphylokinase	1	145	1
serious	Ischaemic stroke	Nervous system disorders	Alteplase	0	146	0
serious	Haemorrhagic stroke	Nervous system disorders	Recombinant Nonimmunogenic Staphylokinase	0	145	0
serious	Haemorrhagic stroke	Nervous system disorders	Alteplase	3	146	3

1 to 10 of 20Source ClinicalTrials.gov

See all 20 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Recombinant Nonimmunogenic Staphylokinase	6	145
Total, all-cause mortality	Alteplase	4	146
Total, other adverse events	Recombinant Nonimmunogenic Staphylokinase	72	155
Total, other adverse events	Alteplase	86	155
Total, serious adverse events	Recombinant Nonimmunogenic Staphylokinase	9	145
Total, serious adverse events	Alteplase	17	146

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
40391253	DERIVED

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 comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Recombinant Nonimmunogenic Staphylokinase vs Alteplase: Death From All Causes	Trial comparisons
Recombinant Nonimmunogenic Staphylokinase vs Alteplase: Death From PE	Trial comparisons
Recombinant Nonimmunogenic Staphylokinase vs Alteplase: deaths from any cause	Trial comparisons
Recombinant Nonimmunogenic Staphylokinase vs Alteplase: Death From All Causes	Trial comparisons
Recombinant Nonimmunogenic Staphylokinase vs Alteplase: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT04688320

GET https://conductscience.org/api/trials/v1/NCT04688320/results?page=2

API reference For AI assistants