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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2017-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Induced Hypertension for Acute Ischemic Stroke

NCT00227448

Acute Ischemic Stroke

COMPLETED PHASE2

China Antihypertensive Trial in Acute Ischemic Stroke

NCT01840072

Ischemic Stroke

COMPLETED NA

Study on the Effectiveness and Safety of Shuxinin Injection in the Treatment of Acute Ischemic Stroke

NCT04950790

Acute Ischemic Stroke

UNKNOWN PHASE4

Effectiveness of Yangxue Qingnao Granules in Preventing Post Thrombolytic Hemorrhage Transformation in Patients With Acute Cerebral Infarction

NCT06344312

Stroke, Acute Ischemic

ACTIVE_NOT_RECRUITING NA

Efficacy and Safety of Tenecteplase Intravenous Thrombolysis in Acute Posterior Circulation Ischemic Stroke Within 4.5-24 Hours After Onset

NCT07094763

Acute Ischemic Stroke

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

See below

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stroke, Acute Progressing Stroke

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Phenylephrine

Phenylephrine induced-hypertension arm

Group Type EXPERIMENTAL

Phenylephrine

Intervention Type DRUG

Phenylephrine (0.12mg/mL) Starting dose: 10cc/hr Titration: increase 10cc/hr every 30-60min, maximum 160cc/hr rate: increase systolic blood pressure (SBP) 10-25mmHg /hr Target: initially 20% increase of initial SBP, up to improving NIHSS score or SBP 200mmHg

Conventional treatment

Control arm

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Phenylephrine

Phenylephrine (0.12mg/mL) Starting dose: 10cc/hr Titration: increase 10cc/hr every 30-60min, maximum 160cc/hr rate: increase systolic blood pressure (SBP) 10-25mmHg /hr Target: initially 20% increase of initial SBP, up to improving NIHSS score or SBP 200mmHg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No