Clinical trial NCT01600235: Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)
Official title: Safety and Efficacy of Therapeutic Induced Hypertension in Patients With Acute Non-cardioembolic Ischemic Stroke: A Multicenter, Randomized, Open Label, Prospective, Phase 3 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Stroke, Acute
Progressing Stroke
Keywords: Stroke, ischemic
Progression
Induced-hypertension
Phenylephrine
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
Collaborators: name: Inje University
name: Gyeongsang National University Hospital
name: Seoul National University Bundang Hospital
name: Keimyung University Dongsan Medical Center
name: Yeungnam University Hospital
First posted: 2012-05-17
Enrollment: 170
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the induced hypertension using phenylephrine in patients with noncardioembolic ischemic stroke.

The investigators hypothesized that phenylephrine induced-hypertension can result in good clinical response without serious complications in patients with noncardioembolic ischemic stroke.

Detailed description: See below

Eligibility criteria: Inclusion Criteria:

* Patients with acute ischemic stroke confirmed by diffusion-weighted imaging (DWI) performed within 24 hours of symptom onset or symptom worsening(defined by a 2-point or more increase in NIH stroke scale (NIHSS)score including one or more increase in the motor score of affected upper and lower limbs in NIHSS during hospitalization or clear history of symptom worsening judged by investigator before hospitalization) confirmed by DWI performed within 24 hours of aggravation.
* Baseline NIHSS score 4-18 points
* Alert mental status
* Newly developed paresis, aphasia, or neglect

Exclusion Criteria:

* Patients underwent recanalization therapy
* Systolic blood pressure \>170 mmHg at baseline
* Patients with history or at risk of hemorrhagic stroke
* History of significant arrhythmia (e.g. atrial fibrillation)
* Unable to perform MRI scans or undergo MRI scans \> 24 hours of symptom onset or progression
* Large cortical infarction on DWI (more than 1/2 of middle cerebral artery territory)
* 3 or more cortical microbleeds on gradient-echo MRI
* Coronary artery disease, congestive heart failure, or hypertrophic cardiomyopathy
* Anticoagulation therapy (phenylephrine group only)
* Patients with high-risk cardioembolic sources
* Cervical or cerebral artery dissection or unruptured aortic/cerebral arterial aneurysm
* Decreased consciousness
* Pregnant or Lactating patient
* Seizure at stroke onset
* Life expectancy \< 6 months
* Pre-stroke modified Rankin scale (mRS) \>= 2
* Patients without informed consent

Primary outcomes:
measure: Primary outcome
timeFrame: Day 0 and Day 7
Secondary outcomes:
measure: Secondary efficacy outcome
timeFrame: Day 90 for 1, 2 and Day 7 for 3
measure: Major safety outcome
timeFrame: From date of randomization until the date of first documented progression by intracranial hemorrhage or cerebral edema, date of myocardial infarction, or date of death from any cause, whichever came first, assessed up to 3 months
measure: Minor safety outcome
timeFrame: From date of randomization until the date of first documented intracranial hemorrhage on follow-up MRI, or date of first documented side effects, whichever came first, assessed up to 3 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Sungkyunkwan University School of Medicine
Study officials:
affiliation: Samsung Medical Center
name: Oh Young Bang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang OY, Chung JW, Kim SK, Kim SJ, Lee MJ, Hwang J, Seo WK, Ha YS, Sung SM, Kim EG, Sohn SI, Han MK. Therapeutic-induced hypertension in patients with noncardioembolic acute stroke. Neurology. 2019 Nov 19;93(21):e1955-e1963. doi: 10.1212/WNL.0000000000008520. Epub 2019 Oct 23.