UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058302 |
|---|---|
| Receipt number | R000066651 |
| Scientific Title | A Quasi-Randomized Controlled Trial of Clopidogrel- or Prasugrel-Based Dual Antiplatelet Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease |
| Date of disclosure of the study information | 2025/06/27 |
| Last modified on | 2025/06/27 15:03:42 |
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Basic information
Public title
A Study Comparing Acute Phase Antiplatelet Therapies for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease
Acronym
BRAVE Trial
Scientific Title
A Quasi-Randomized Controlled Trial of Clopidogrel- or Prasugrel-Based Dual Antiplatelet Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease
Scientific Title:Acronym
A Quasi-Randomized Controlled Trial of Clopidogrel- or Prasugrel-Based Dual Antiplatelet Therapy for the Prevention of Early Neurological Deterioration in Branch Atheromatous Disease
Region
| Japan |
Condition
Condition
Branch Atheromatous Disease (BAD)-type Cerebral Infarction
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to compare the effectiveness of clopidogrel plus aspirin versus prasugrel plus aspirin as acute-phase dual antiplatelet therapy (DAPT) in patients with Branch Atheromatous Disease (BAD), focusing on the prevention of early neurological deterioration (END). This quasi-randomized controlled trial aims to determine the optimal DAPT regimen for acute BAD.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Early neurological deterioration (END) occurring within 48 hours and within 7 days after the initiation of treatment.
END is defined as a worsening of the total NIHSS (National Institutes of Health Stroke Scale) score by 2 points or more.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
FFor patients with Branch Atheromatous Disease, clopidogrel is administered with a loading dose of 300 mg orally (75 mg x 4), followed by a maintenance dose of 75 mg/day. Aspirin is co-administered at 100 mg/day (a loading dose of 100-200 mg is allowed at the discretion of the attending physician). Argatroban is administered from day 1 for 7 days at the standard dosage. Edaravone is also given as part of standard care.
Interventions/Control_2
For patients with Branch Atheromatous Disease, prasugrel is administered orally at 3.75 mg/day. Aspirin is co-administered at 100 mg/day (a loading dose of 100-200 mg is allowed at the discretion of the attending physician). Argatroban is administered from day 1 for 7 days at the standard dosage. Edaravone is also given as part of standard care.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who meet all of the following criteria are eligible for inclusion:
1. Acute cerebral infarction diagnosed as Branch Atheromatous Disease (BAD) within 24 hours of onset
2. Age >= 20 years
3. Written informed consent obtained from the patient or a legally authorized representative
Key exclusion criteria
Patients will be excluded if they meet any of the following criteria:
Received acute reperfusion therapy (intravenous tPA or endovascular treatment)
Severe stenosis (>50%) or occlusion of the responsible artery
Strong suspicion of cardiogenic cerebral embolism (e.g., atrial fibrillation)
Active bleeding or bleeding tendency
Receiving anticoagulant therapy other than antiplatelet agents
History of allergy to prasugrel or clopidogrel
Ineligible for MRI (e.g., pacemaker, metallic implant, severe claustrophobia)
Deemed inappropriate for participation by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Noriko |
| Middle name | |
| Last name | Arai |
Organization
Saitama Medical University International Medical Center
Division name
Department of Neurology and Cerebrovascular Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama
TEL
+81-42-984-4359
ideguchi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Noriko |
| Middle name | |
| Last name | Arai |
Organization
Saitama Medical University International Medical Center
Division name
Department of Neurology and Cerebrovascular Medicine
Zip code
350-1298
Address
1397-1 Yamane, Hidaka, Saitama
TEL
+81-42-984-4359
Homepage URL
ideguchi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
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
the Human Research Ethics Committee of Saitama Medical University International Medical Center
Address
1397-1 Yamane, Hidaka, Saitama
Tel
042-985-4220
saitama-med@esct.bvits.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 27 | 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
Results Delay Reason
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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 27 | Day |
Last modified on
| 2025 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066651
