18 and older, any sex, with Acute Stroke or Endovascular Thrombectomy. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Final Infarct VolumePrimary· 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.
Group
Value
95% CI
Higher Systolic Blood Pressure (SBP) Target
46.4
24.5 – 68.2
Lower SBP (<160 mmHg) Target
50.7
33.7 – 67.7
Lower SBP (<140mmHg) Target
32.4
18.0 – 46.7
Utility-weighted Modified Rankin ScorePrimary· 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 dis
Group
Value
95% CI
Higher Systolic Blood Pressure (SBP) Target
0.58
0.46 – 0.71
Lower SBP (<160 mmHg) Target
0.47
0.35 – 0.6
Lower SBP (<140mmHg) Target
0.51
0.38 – 0.63
Number of Participants With Any Hemorrhagic TransformationSecondary· 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
Group
Value
95% CI
Higher Systolic Blood Pressure (SBP) Target
12
Lower SBP (<160 mmHg) Target
12
Lower SBP (<140mmHg) Target
14
Number of Participants With Symptomatic Hemorrhagic TransformationSecondary· 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
Group
Value
95% CI
Higher Systolic Blood Pressure (SBP) Target
2
Lower SBP (<160 mmHg) Target
1
Lower SBP (<140mmHg) Target
2
Number of Participants With Neurological Worsening Associated With Antihypertensive TreatmentSecondary· 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.
Group
Value
95% CI
Higher Systolic Blood Pressure (SBP) Target
0
Lower SBP (<160 mmHg) Target
0
Lower SBP (<140mmHg) Target
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Through hospital stay, up to 30 days.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Higher Systolic Blood Pressure (SBP) Target
Serious: 1/40 (3%)
Deaths: 3/40
Lower SBP (<160 mmHg) Target
Serious: 3/40 (8%)
Deaths: 6/40
Lower SBP (<140mmHg) Target
Serious: 4/40 (10%)
Deaths: 3/40
Serious adverse events (7 terms)
Reaction
System
Higher Systolic Blood Pres…
Lower SBP (<160 mmHg) Target
Lower SBP (<140mmHg) Target
Aspiration Pneumonia
Infections and infestations
—
—
—
Femoral artery Pseudoaneurysm
Vascular disorders
—
—
—
Sepsis and cardiac failure
Infections and infestations
—
—
—
Carotid artery re-occlusion
Vascular disorders
—
—
—
Subarachnoid hemorrhage
Nervous system disorders
—
—
—
Gastrointestinal hemorrhage associated with gastric ulcer
The purpose of this study is to assess the safety of lowering blood pressure in acute stroke patients that are successfully treated with a mechanical thrombectomy procedure. The investogators will evaluate the hypothesis that lower blood pressure management strategies do not result in larger volume of stroke or worse 3-month clinical outcome in these patients.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07364201 — A Comparison of Nicardipine and Labetalol for Blood Pressure Control in Intensive Care Patients After Hemorrhagic Stroke
· NA
· completed
NCT07044232 — NICardipine for Fast Achievement of Systolic BP Targets in ICH
· Phase 4
· not yet recruiting
NCT06093893 — Hypotensive Anesthesia for Orthognathic Surgery
· Phase 4
· completed
NCT06130527 — Comparison of the Effects of Nicardipine and Remifentanil on Surgical Visual Field
· NA
· unknown
NCT05625503 — Dilution of Verapamil During Intraarterial Administration
· EARLY_PHASE1
· completed
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Trials by the same sponsor.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Cincinnati
Last refreshed: 12 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04116112.