UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055204 |
|---|---|
| Receipt number | R000063078 |
| Scientific Title | Clinical trials on the efficacy and safety of enhanced antihypertensive therapy in the Immediately post onset of non-traumatic intracerebral haemorrhage. |
| Date of disclosure of the study information | 2024/08/09 |
| Last modified on | 2025/12/18 21:06:07 |
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Basic information
Public title
Clinical trials on the efficacy and safety of enhanced antihypertensive therapy in the Immediately post onset of non-traumatic intracerebral haemorrhage.
Acronym
Clinical Trial on Efficacy and Safety of Enhanced Antihypertensive Therapy for Intracerebral Hemorrhage
Scientific Title
Clinical trials on the efficacy and safety of enhanced antihypertensive therapy in the Immediately post onset of non-traumatic intracerebral haemorrhage.
Scientific Title:Acronym
Clinical trials on the efficacy and safety of enhanced antihypertensive therapy in the Immediately post onset of non-traumatic intracerebral haemorrhage.
Region
| Japan |
Condition
Condition
Non-Traumatic Intracerebral Hemorrhage
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To establish that early reduction of systolic blood pressure below 120 mmHg can prevent hematoma enlargement without increasing adverse events and improve outcomes in patients with non-traumatic intracerebral hemorrhage, especially those at risk for hematoma enlargement.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hematoma enlargement or not
Key secondary outcomes
Presence of renal dysfunction, functional prognosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In the diagnosis of non-traumatic intracerebral hemorrhage, a contrast-enhanced CT scan is performed to investigate the cause of the hemorrhage. If surgery is indicated depending on the location and extent of the hematoma, craniotomy is performed to remove the hematoma. For conservative treatment, patients with a leakage sign on contrast-enhanced CT scan are divided into two groups: the intensified antihypertensive treatment group and the conventional antihypertensive treatment group. The dose of nicardipine hydrochloride and nitroglycerin should be increased to keep systolic blood pressure below 120 mmHg for 6 hours after onset and below 140 mmHg for 7 days thereafter. If systolic blood pressure falls below 80 mmHg, the drug is reduced to bring it within the target range.
Interventions/Control_2
Antihypertensive therapy according to the guidelines as before
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with non-traumatic intracerebral hemorrhage and positive Leakage sign on contrast-enhanced CT scan are eligible.
Patients who are between 20 and 90 years of age at the time of consent.
Patients who have obtained written consent from the patient or a surrogate.
Patients whose respiratory and circulatory status is stable from the time of admission to the contrast CT scan.
Key exclusion criteria
Pregnant women or those who may be pregnant
Patients whose respiratory and circulatory status has not stabilized between the time of admission and the contrast-enhanced CT scan.
Those who have been resuscitated after cardiopulmonary arrest
Those who are judged to be unsuitable as research subjects by the principal investigator and research coordinators.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sosho |
| Middle name | |
| Last name | Kajiwara |
Organization
Kurume University School of Medicine
Division name
Department of Neurosurgery
Zip code
830-0011
Address
67, Asahimachi Kurume City, Fukuoka, Japan
TEL
0942-31-7570
kajiwara_soushou@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Sosho |
| Middle name | |
| Last name | Kajiwara |
Organization
Kurume University School of Medicine
Division name
Department of Neurosurgery
Zip code
830-0011
Address
67, Asahimachi Kurume City, Fukuoka, Japan
TEL
0942-31-7570
Homepage URL
kajiwara_soushou@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kurume University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kurume University School of Medicine
Address
67, Asahimachi Kurume City, Fukuoka, Japan
Tel
0942-31-7570
kajiwara_soushou@med.kurume-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
23126
Org. issuing International ID_1
Kurume University School of Medicine Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Insufficient number of registered patients
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2023 | Year | 09 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2028 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2028 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 09 | Day |
Last modified on
| 2025 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063078
