Trial · NCT04116112
Blood Pressure After Endovascular Stroke Therapy-II
NCT04116112, Phase 2, Completed, University of Cincinnati; results first posted 2023-10-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Blood Pressure After Endovascular Stroke Therapy-II. Trials, record NCT04116112. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04116112
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Blood Pressure After Endovascular Stroke Therapy-II
- NCT number
- NCT04116112
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 120 participants, actual
- Lead sponsor
- University of Cincinnati
- Conditions
- Acute Stroke, Endovascular Thrombectomy
- Interventions
- Nicardipine, Labetalol, Hydralazine
- First posted
- 2019-10-04
- Last updated
- 2023-10-12
- Results first posted
- 2023-10-12
- Limitations and caveats
- Participants enrolled at only three sites across the US
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Final Infarct Volume | 36 (+/-12) hrs after treatment initiation | Infarct volume on diffusion-weighted MRI (or CT if MRI cannot be obtained) at 36 (+/-12) hrs after treatment initiation, adjusted for the baseline CT perfusion core infract volume. |
| Primary | Utility-weighted Modified Rankin Score | 90 days after treatment initiation | Modified Rankin score (mRS) is a scale for measuring the degree of disability or dependence of people who have suffered a stroke. 0 - no symptoms at all; 1 - no significant disability despite symptoms; able to carry out all usual duties and activities; 2- slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; 3- moderate disability; requiring some help, but able to walk without assistance; 4 - moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; 5 - severe disability; bedridden, incontinent and requiring constant nursing care and attention; 6- dead. Patient centered utility weights are applied to these scores as 1.0 for mRS level 0; 0.91 for mRS level 1; 0.76 for mRS level 2; 0.65 for mRS level 3; 0.33 for mRS level 4; 0 for mRS level 5; and 0 for mRS level 6. Unlike the mRS, the utility-weighted mRS runs from 0 to 1, with 0 being the worst. |
| Secondary | Number of Participants With Any Hemorrhagic Transformation | 36(+/-12) hrs after treatment initiation | Number of participants with any new bleeding within the infarcted brain tissue on 36(+/-12) hr MRI/CT scan after treatment initiation |
| Secondary | Number of Participants With Symptomatic Hemorrhagic Transformation | 36(+/-12) hrs after treatment initiation | Defined as number of participants with any new bleeding within the infarcted brain tissue and an NIH Stroke Scale worsening of 4 or more points associated with the bleeding within 36 (+/-12) hrs of treatment initiation |
| Secondary | Number of Participants With Neurological Worsening Associated With Antihypertensive Treatment | Treatment initiation to 24 hrs after treatment initiation | Defined as number of participants with 4 points of greater increase in NIH Stroke scale associated with reduction in SBP caused by anti-hypertensive treatment initiation or titration. |
| Other | Compliance Outcome | Treatment initiation to 24 hrs after treatment Initiation | Number of participants with an hourly maximum SBP above target from 2-24 hrs post treatment initiation |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Final Infarct Volume | 36 (+/-12) hrs after treatment initiation | Cubic Centimeters | MEAN | |
| PRIMARY | Utility-weighted Modified Rankin Score | 90 days after treatment initiation | units on a scale (Range 0-1; 1=best) | MEAN | |
| SECONDARY | Number of Participants With Any Hemorrhagic Transformation | 36(+/-12) hrs after treatment initiation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Symptomatic Hemorrhagic Transformation | 36(+/-12) hrs after treatment initiation | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Neurological Worsening Associated With Antihypertensive Treatment | Treatment initiation to 24 hrs after treatment initiation | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Compliance Outcome | Treatment initiation to 24 hrs after treatment Initiation |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Final Infarct Volume | Higher Systolic Blood Pressure (SBP) Target | 46.4 | 95% Confidence Interval 24.5 to 68.2 | Cubic Centimeters | |
| Final Infarct Volume | Lower SBP (<160 mmHg) Target | 50.7 | 95% Confidence Interval 33.7 to 67.7 | Cubic Centimeters | |
| Final Infarct Volume | Lower SBP (<140mmHg) Target | 32.4 | 95% Confidence Interval 18.0 to 46.7 | Cubic Centimeters | |
| Utility-weighted Modified Rankin Score | Higher Systolic Blood Pressure (SBP) Target | 0.58 | 95% Confidence Interval 0.46 to 0.71 | units on a scale (Range 0-1; 1=best) | |
| Utility-weighted Modified Rankin Score | Lower SBP (<160 mmHg) Target | 0.47 | 95% Confidence Interval 0.35 to 0.6 | units on a scale (Range 0-1; 1=best) | |
| Utility-weighted Modified Rankin Score | Lower SBP (<140mmHg) Target | 0.51 | 95% Confidence Interval 0.38 to 0.63 | units on a scale (Range 0-1; 1=best) | |
| Number of Participants With Any Hemorrhagic Transformation | Higher Systolic Blood Pressure (SBP) Target | 12 | Participants | ||
| Number of Participants With Any Hemorrhagic Transformation | Lower SBP (<160 mmHg) Target | 12 | Participants | ||
| Number of Participants With Any Hemorrhagic Transformation | Lower SBP (<140mmHg) Target | 14 | Participants | ||
| Number of Participants With Symptomatic Hemorrhagic Transformation | Higher Systolic Blood Pressure (SBP) Target | 2 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Higher Systolic Blood Pressure (SBP) Target | 40 | |
| Overall Study | STARTED | Lower SBP (<160 mmHg) Target | 40 | |
| Overall Study | STARTED | Lower SBP (<140mmHg) Target | 40 | |
| Overall Study | COMPLETED | Higher Systolic Blood Pressure (SBP) Target | 39 | |
| Overall Study | COMPLETED | Lower SBP (<160 mmHg) Target | 36 | |
| Overall Study | COMPLETED | Lower SBP (<140mmHg) Target | 38 | |
| Overall Study | NOT COMPLETED | Higher Systolic Blood Pressure (SBP) Target | 1 | |
| Overall Study | NOT COMPLETED | Lower SBP (<160 mmHg) Target | 4 | |
| Overall Study | NOT COMPLETED | Lower SBP (<140mmHg) Target | 2 |
Source ClinicalTrials.gov
Adverse events21
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 |
|---|---|---|---|---|---|---|
| serious | Femoral artery Pseudoaneurysm | Vascular disorders | Higher Systolic Blood Pressure (SBP) Target | 1 | 40 | |
| serious | Femoral artery Pseudoaneurysm | Vascular disorders | Lower SBP (<160 mmHg) Target | 0 | 40 | |
| serious | Femoral artery Pseudoaneurysm | Vascular disorders | Lower SBP (<140mmHg) Target | 0 | 40 | |
| serious | Sepsis and cardiac failure | Infections and infestations | Higher Systolic Blood Pressure (SBP) Target | 0 | 40 | |
| serious | Sepsis and cardiac failure | Infections and infestations | Lower SBP (<160 mmHg) Target | 1 | 40 | |
| serious | Sepsis and cardiac failure | Infections and infestations | Lower SBP (<140mmHg) Target | 0 | 40 | |
| serious | Aspiration Pneumonia | Infections and infestations | Higher Systolic Blood Pressure (SBP) Target | 0 | 40 | |
| serious | Aspiration Pneumonia | Infections and infestations | Lower SBP (<160 mmHg) Target | 2 | 40 | |
| serious | Aspiration Pneumonia | Infections and infestations | Lower SBP (<140mmHg) Target | 0 | 40 | |
| serious | Carotid artery re-occlusion | Vascular disorders | Higher Systolic Blood Pressure (SBP) Target | 0 | 40 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Higher Systolic Blood Pressure (SBP) Target | 3 | 40 |
| Total, all-cause mortality | Lower SBP (<160 mmHg) Target | 6 | 40 |
| Total, all-cause mortality | Lower SBP (<140mmHg) Target | 3 | 40 |
| Total, other adverse events | Higher Systolic Blood Pressure (SBP) Target | 0 | 40 |
| Total, other adverse events | Lower SBP (<160 mmHg) Target | 0 | 40 |
| Total, other adverse events | Lower SBP (<140mmHg) Target | 0 | 40 |
| Total, serious adverse events | Higher Systolic Blood Pressure (SBP) Target | 1 | 40 |
| Total, serious adverse events | Lower SBP (<160 mmHg) Target | 3 | 40 |
| Total, serious adverse events | Lower SBP (<140mmHg) Target | 4 | 40 |
Source ClinicalTrials.gov
Papers2
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 |
|---|---|---|---|---|---|
| K23NS113858 | Blood Pressure after Endovascular Stroke Therapy-II: A Randomized Trial | MISTRY, EVA | UNIVERSITY OF CINCINNATI | NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE | 2019 to 2023 |
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/NCT04116112
GET https://conductscience.org/api/trials/v1/NCT04116112/events?page=2