Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)

Samsung Medical Center

Status and phase

Unknown

Phase 3

Conditions

Stroke, Acute

Progressing Stroke

Treatments

Drug: Phenylephrine

Study type

Interventional

Funder types

Other

Identifiers

NCT01600235

2012-01-023

Details and patient eligibility

About

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.

Full description

See below

Enrollment

170 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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