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Trial · NCT03735979

Multi-arm Optimization of Stroke Thrombolysis

NCT03735979, Phase 3, Completed, Washington University School of Medicine; results first posted 2024-11-19

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Multi-arm Optimization of Stroke Thrombolysis. Trials, record NCT03735979. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03735979

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Trial

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

Title
Multi-arm Optimization of Stroke Thrombolysis
NCT number
NCT03735979
Status
Completed
Phases
Phase 3
Enrollment
514 participants, actual
Lead sponsor
Washington University School of Medicine
Conditions
Acute Ischemic Stroke
Interventions
Argatroban, Eptifibatide, Placebo
First posted
2018-11-08
Last updated
2025-02-07
Results first posted
2024-11-19

Source ClinicalTrials.gov

Registered outcomes13

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

ListOutcomeTime frameDescription
Primary90-day Utility Weighted Modified Rankin Scores (UW-mRS)90 days after randomization
The modified Rankin scale is a 7 point ordinal scale ranging from 0="no symptoms" to 6="death" . For the primary analysis, the scale was analyzed with patient-centered utility weights. We assigned the following utility weights to the seven levels: 10, 9.1,, 7.6, 6.5, 3.3, 0, 0 (with higher scores indicating a better outcome).
SecondaryPercentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours24 hours after randomization
National Institute of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating worse neurologic deficit. This is a dichotomous analysis with a cutpoint of 0,1,2 defining the event.
SecondaryChange From Baseline to 24-hour NIHSS24 hours after randomizationNational Institute of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating worse neurologic deficit.
SecondaryPercentage of Participants With 90-day mRS 0 or 1 (or Return to Their Historical mRS)90 days after randomization
The modified Rankin scale (mRS) is a 7 point scale ranging from 0="no symptoms" to 6="death" where lower scores are better outcomes. For patients with a pre-stroke mRS of greater than 0 or 1, these patients had to return to their historical (pre-stroke) value to be counted as a success.
SecondaryPercentage of Participants With 90-day mRS 0, 1 or 2 (or Return to Their Historical mRS)90 days after randomizationmodified Rankin scale is a 7 point scale ranging from 0="no symptoms" to 6="death" where lower scores are better outcomes.
Secondary90-day mRS90 days after randomizationmodified Rankin scale is a 7 point ordinal scale ranging from 0="no symptoms at all" to 6="death" where lower scores are better outcomes.
Secondary90-day EQ-5D90 days after randomizationEuroQol Five-Dimension (EQ-5D) is a measure of health-related quality of life ranging from -0.59 to 1 where 1 is the best possible health state.
SecondaryPre-thrombectomy Modified TICI Score of 2B.baseline
The modified thrombolysis in cerebral infarction (TICI) score prior to endovascular thrombectomy procedure. The modified pre-thrombectomy TICI score is a 4 point scale with possible values of 0, 1, 2A, and 2B. The values are defined as follows: 0=No flow, 1=Penetration without distal branch filling, 2A=\<50% partial reperfusion, and 2B=50%-99% partial reperfusion.
SecondaryPost-thrombectomy Modified TICI Score of 2B or 3baseline
The modified thrombolysis in cerebral infarction (TICI) score prior to endovascular thrombectomy procedure. The modified post-thrombectomy TICI score is a 5 point scale with possible values of 0, 1, 2A, 2B, 3. The values are defined as follows: 0=No flow, 1=Penetration without distal branch filling, 2A=\<50% partial reperfusion, 2B=50%-99% partial reperfusion, and 3=Completed reperfusion
OtherSymptomatic Intracranial Hemorrhage Within 36 Hours (Primary Safety Outcome)36 hours after randomization
Type 2 parenchymal hemorrhage or a parenchymal hemorrhage remote from the area of infarction with neurologic deterioration (defined as an increase of ≥4 points in the NIHSS score)within 36 hours after randomization.

Outcomes13

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

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARY90-day Utility Weighted Modified Rankin Scores (UW-mRS)90 days after randomizationIntention-to-treatscore on a scaleMEAN
SECONDARYPercentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours24 hours after randomizationParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYChange From Baseline to 24-hour NIHSS24 hours after randomizationunits on a scaleMEAN
SECONDARYPercentage of Participants With 90-day mRS 0 or 1 (or Return to Their Historical mRS)90 days after randomizationIntention-to-treat sampleParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPercentage of Participants With 90-day mRS 0, 1 or 2 (or Return to Their Historical mRS)90 days after randomizationIntention-to-treatParticipantsCOUNT_OF_PARTICIPANTS
SECONDARY90-day mRS90 days after randomizationIntention-to-treatunits on a scaleMEDIAN
SECONDARY90-day EQ-5D90 days after randomizationscore on a scaleMEAN
SECONDARYPre-thrombectomy Modified TICI Score of 2B.baselineOnly participants that received endovascular thrombectomy are analyzed for this outcome.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYPost-thrombectomy Modified TICI Score of 2B or 3baselineOnly participants that received endovascular thrombectomy are analyzed for this outcome.ParticipantsCOUNT_OF_PARTICIPANTS
OTHER_PRE_SPECIFIEDSymptomatic Intracranial Hemorrhage Within 36 Hours (Primary Safety Outcome)36 hours after randomizationParticipants that took any amount of study drug (safety sample)ParticipantsCOUNT_OF_PARTICIPANTS

Results by group39

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

OutcomeGroupCategoryValueSpreadUnits
90-day Utility Weighted Modified Rankin Scores (UW-mRS)Argatroban5.2Standard Deviation 3.7score on a scale
90-day Utility Weighted Modified Rankin Scores (UW-mRS)Eptifibatide6.3Standard Deviation 3.2score on a scale
90-day Utility Weighted Modified Rankin Scores (UW-mRS)Placebo6.8Standard Deviation 3.0score on a scale
Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 HoursArgatroban14Participants
Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 HoursEptifibatide84Participants
Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 HoursPlacebo89Participants
Change From Baseline to 24-hour NIHSSArgatroban-5.1Standard Deviation 9.3units on a scale
Change From Baseline to 24-hour NIHSSEptifibatide-6.1Standard Deviation 8.4units on a scale
Change From Baseline to 24-hour NIHSSPlacebo-6.3Standard Deviation 6.8units on a scale
Percentage of Participants With 90-day mRS 0 or 1 (or Return to Their Historical mRS)Argatroban14Participants

Participant flow9

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

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDArgatroban59
Overall StudySTARTEDEptifibatide227
Overall StudySTARTEDPlacebo228
Overall StudyCOMPLETEDArgatroban56
Overall StudyCOMPLETEDEptifibatide210
Overall StudyCOMPLETEDPlacebo212
Overall StudyNOT COMPLETEDArgatroban3
Overall StudyNOT COMPLETEDEptifibatide17
Overall StudyNOT COMPLETEDPlacebo16

Adverse events90

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherAnaemiaBlood and lymphatic system disordersArgatroban2592
otherAnaemiaBlood and lymphatic system disordersEptifibatide12271
otherAnaemiaBlood and lymphatic system disordersPlacebo32283
otherAtrial fibrillationCardiac disordersArgatroban2592
otherAtrial fibrillationCardiac disordersEptifibatide52275
otherAtrial fibrillationCardiac disordersPlacebo32283
otherUrinary tract infectionInfections and infestationsArgatroban0590
otherUrinary tract infectionInfections and infestationsEptifibatide32273
otherUrinary tract infectionInfections and infestationsPlacebo22282
otherCoronavirus test positiveInfections and infestationsArgatroban0590

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityArgatroban1354
Total, all-cause mortalityEptifibatide25212
Total, all-cause mortalityPlacebo17217
Total, other adverse eventsArgatroban1259
Total, other adverse eventsEptifibatide42227
Total, other adverse eventsPlacebo33228
Total, serious adverse eventsArgatroban2659
Total, serious adverse eventsEptifibatide85227
Total, serious adverse eventsPlacebo78228

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
33297893DERIVEDPubMed
37256980DERIVEDPubMed
39231343DERIVEDPubMed
40123511DERIVEDPubMed
40824660DERIVEDPubMed
41071964DERIVEDPubMed

Grants1

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.

ProjectTitlePrincipal investigatorsOrganizationFunderFiscal years
U01NS100699Multi-arm Optimization of Stroke Thrombolysis (MOST) Stroke TrialADEOYE, OPEOLU M; BARRETO, ANDREW D; BRODERICK, JOSEPH PAUL; DERDEYN, COLIN PIETER; GROTTA, JAMES CWASHINGTON UNIVERSITYNATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE2018 to 2021

Trial comparisons0

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

None in this release.

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/NCT03735979

GET https://conductscience.org/api/trials/v1/NCT03735979/results?page=2