Stroke, AcutePhase 3NCT01600235
Safety and Efficacy of Therapeutic INduced HYPERTENSION in Acute Non-cardioembolic Ischemic Stroke (SETIN-HYPERTENSION)
A Phase 3 study testing Phenylephrine in people with Stroke, Acute and Progressing Stroke, run by Samsung Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stroke, Acute, Progressing Stroke
- What is being tested?
- Phenylephrine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Dec 2017
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135710
Suk Jae Kim, MD, 82234101895, sukjae.kim@gmail.com
Oh Young Bang, MD
About this study
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
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.
Read the detailed description
See below
- Conditions
- Stroke, Acute, Progressing Stroke
- Being tested
- Phenylephrine
- Keywords
- Stroke, ischemic, Progression, Induced-hypertension, Phenylephrine
- Medical subject headings
- Stroke, Ischemic Stroke, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhenylephrineDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Phenylephrine | Experimental | Phenylephrine induced-hypertension arm Receives: Drug: Phenylephrine |
| Conventional treatment | No intervention | Control arm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
Measured: Day 0 and Day 7
Secondary outcomes (3)
Secondary efficacy outcome
- modified Rankin scale (mRS)≤ 2 at day 90
- modified Bathel index (mBI)≥ 90 at day 90
- Infarct growth or new ischemic lesion on follow-up MRI
Measured: Day 90 for 1, 2 and Day 7 for 3
Major safety outcome
- Symptom aggravation by intracranial hemorrhage or cerebral edema (Clinical deterioration causing an increase in the NIHSS score of more than or equal to 4 points and if the hemorrhage or edema was liley to be the cause of the clinical deterioration)
- Myocardial infarction
- death from any cause
Measured: 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
Minor safety outcome
- Intracranial hemorrhage on follow-up MRI
- Side effects including headache, arrhythmia, chest pain, dysuria, or gastrointestinal hemorrhage
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startJun 2012
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Inje University, Gyeongsang National University Hospital, Seoul National University Bundang Hospital, Keimyung University Dongsan Medical Center, Yeungnam University Hospital
- Responsible party
- Principal investigator, Oh Young Bang, Samsung Medical Center
- Investigators
- Oh Young Bang, MD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600235
- Sponsor's protocol ID
- 2012-01-023
- Status last verified
- Apr 2017
- First submitted
- 13 May 2012
- Last updated
- 26 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 31645472
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01600235
- Acronym / sponsor ID
- 2012-01-023
- Conditions
- Stroke, Acute, Progressing Stroke
- Keywords
- Stroke, ischemic, Progression, Induced-hypertension, Phenylephrine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Inje University, Gyeongsang National University Hospital, Seoul National University Bundang Hospital, Keimyung University Dongsan Medical Center, Yeungnam University Hospital
- Study start
- Jun 2012
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 17 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phenylephrine | Experimental | Drug: PhenylephrinePhenylephrine induced-hypertension arm |
| Conventional treatment | No intervention | –Control arm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PhenylephrinePhenylephrine (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 | Drug | Phenylephrine |
Primary outcome
Primary outcome
Time frame: Day 0 and Day 7
2 points improvement in NIH stroke scale (NIHSS) between days 0 and 7
3 secondary outcomes
Secondary efficacy outcome
Time frame: Day 90 for 1, 2 and Day 7 for 3
Major safety outcome
Time frame: 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
Minor safety outcome
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2017.
- Derived from this study: PubMed 31645472Bang 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.
Related trials for Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oh Young Bang, MD principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phenylephrine in people with Stroke, Acute and Progressing Stroke, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oh Young Bang, MD (82-10-3410-3599, nmboy@unitel.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary outcome (time frame: Day 0 and Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01600235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2017.