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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 90-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). |
| Secondary | Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours | 24 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. |
| Secondary | Change From Baseline to 24-hour NIHSS | 24 hours after randomization | National Institute of Health Stroke Scale (NIHSS) scores range from 0 to 42, with higher scores indicating worse neurologic deficit. |
| Secondary | Percentage 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. |
| Secondary | Percentage of Participants With 90-day mRS 0, 1 or 2 (or Return to Their Historical mRS) | 90 days after randomization | modified Rankin scale is a 7 point scale ranging from 0="no symptoms" to 6="death" where lower scores are better outcomes. |
| Secondary | 90-day mRS | 90 days after randomization | modified Rankin scale is a 7 point ordinal scale ranging from 0="no symptoms at all" to 6="death" where lower scores are better outcomes. |
| Secondary | 90-day EQ-5D | 90 days after randomization | EuroQol 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. |
| Secondary | Pre-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. |
| Secondary | Post-thrombectomy Modified TICI Score of 2B or 3 | baseline | 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 |
| Other | Symptomatic 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 90-day Utility Weighted Modified Rankin Scores (UW-mRS) | 90 days after randomization | Intention-to-treat | score on a scale | MEAN |
| SECONDARY | Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours | 24 hours after randomization | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Change From Baseline to 24-hour NIHSS | 24 hours after randomization | units on a scale | MEAN | |
| SECONDARY | Percentage of Participants With 90-day mRS 0 or 1 (or Return to Their Historical mRS) | 90 days after randomization | Intention-to-treat sample | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With 90-day mRS 0, 1 or 2 (or Return to Their Historical mRS) | 90 days after randomization | Intention-to-treat | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 90-day mRS | 90 days after randomization | Intention-to-treat | units on a scale | MEDIAN |
| SECONDARY | 90-day EQ-5D | 90 days after randomization | score on a scale | MEAN | |
| SECONDARY | Pre-thrombectomy Modified TICI Score of 2B. | baseline | Only participants that received endovascular thrombectomy are analyzed for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Post-thrombectomy Modified TICI Score of 2B or 3 | baseline | Only participants that received endovascular thrombectomy are analyzed for this outcome. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Symptomatic Intracranial Hemorrhage Within 36 Hours (Primary Safety Outcome) | 36 hours after randomization | Participants that took any amount of study drug (safety sample) | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group39
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 90-day Utility Weighted Modified Rankin Scores (UW-mRS) | Argatroban | 5.2 | Standard Deviation 3.7 | score on a scale | |
| 90-day Utility Weighted Modified Rankin Scores (UW-mRS) | Eptifibatide | 6.3 | Standard Deviation 3.2 | score on a scale | |
| 90-day Utility Weighted Modified Rankin Scores (UW-mRS) | Placebo | 6.8 | Standard Deviation 3.0 | score on a scale | |
| Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours | Argatroban | 14 | Participants | ||
| Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours | Eptifibatide | 84 | Participants | ||
| Percentage of Participants With NIHSS Less Than or Equal to 2 at 24 Hours | Placebo | 89 | Participants | ||
| Change From Baseline to 24-hour NIHSS | Argatroban | -5.1 | Standard Deviation 9.3 | units on a scale | |
| Change From Baseline to 24-hour NIHSS | Eptifibatide | -6.1 | Standard Deviation 8.4 | units on a scale | |
| Change From Baseline to 24-hour NIHSS | Placebo | -6.3 | Standard Deviation 6.8 | units on a scale | |
| Percentage of Participants With 90-day mRS 0 or 1 (or Return to Their Historical mRS) | Argatroban | 14 | Participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Argatroban | 59 | |
| Overall Study | STARTED | Eptifibatide | 227 | |
| Overall Study | STARTED | Placebo | 228 | |
| Overall Study | COMPLETED | Argatroban | 56 | |
| Overall Study | COMPLETED | Eptifibatide | 210 | |
| Overall Study | COMPLETED | Placebo | 212 | |
| Overall Study | NOT COMPLETED | Argatroban | 3 | |
| Overall Study | NOT COMPLETED | Eptifibatide | 17 | |
| Overall Study | NOT COMPLETED | Placebo | 16 |
Source ClinicalTrials.gov
Adverse events90
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 | Anaemia | Blood and lymphatic system disorders | Argatroban | 2 | 59 | 2 |
| other | Anaemia | Blood and lymphatic system disorders | Eptifibatide | 1 | 227 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 3 | 228 | 3 |
| other | Atrial fibrillation | Cardiac disorders | Argatroban | 2 | 59 | 2 |
| other | Atrial fibrillation | Cardiac disorders | Eptifibatide | 5 | 227 | 5 |
| other | Atrial fibrillation | Cardiac disorders | Placebo | 3 | 228 | 3 |
| other | Urinary tract infection | Infections and infestations | Argatroban | 0 | 59 | 0 |
| other | Urinary tract infection | Infections and infestations | Eptifibatide | 3 | 227 | 3 |
| other | Urinary tract infection | Infections and infestations | Placebo | 2 | 228 | 2 |
| other | Coronavirus test positive | Infections and infestations | Argatroban | 0 | 59 | 0 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Argatroban | 13 | 54 |
| Total, all-cause mortality | Eptifibatide | 25 | 212 |
| Total, all-cause mortality | Placebo | 17 | 217 |
| Total, other adverse events | Argatroban | 12 | 59 |
| Total, other adverse events | Eptifibatide | 42 | 227 |
| Total, other adverse events | Placebo | 33 | 228 |
| Total, serious adverse events | Argatroban | 26 | 59 |
| Total, serious adverse events | Eptifibatide | 85 | 227 |
| Total, serious adverse events | Placebo | 78 | 228 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01NS100699 | Multi-arm Optimization of Stroke Thrombolysis (MOST) Stroke Trial | ADEOYE, OPEOLU M; BARRETO, ANDREW D; BRODERICK, JOSEPH PAUL; DERDEYN, COLIN PIETER; GROTTA, JAMES C | WASHINGTON UNIVERSITY | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2018 to 2021 |
Source NIH RePORTER
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.
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