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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014405
Receipt No. R000016748
Scientific Title Argatroban, aspirin and clopidgrel combination therapy for non-cardioembolic acute ischemic stroke -a prospective, randomized, argatroban and aspirin-controlled study-
Date of disclosure of the study information 2014/06/27
Last modified on 2016/02/01

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Basic information
Public title Argatroban, aspirin and clopidgrel combination therapy for non-cardioembolic acute ischemic stroke -a prospective, randomized, argatroban and aspirin-controlled study-
Acronym Dual antiplatelet therapy for non-cardioembolic acute ischemic stroke
Scientific Title Argatroban, aspirin and clopidgrel combination therapy for non-cardioembolic acute ischemic stroke -a prospective, randomized, argatroban and aspirin-controlled study-
Scientific Title:Acronym Dual antiplatelet therapy for non-cardioembolic acute ischemic stroke
Region
Japan

Condition
Condition Acute non-cardioembolic stroke
Classification by specialty
Neurology Emergency medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Efficacy and safety of combination therapy (argatoroban, aspirin and clopidgrel)
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. NIHSS score at 7 days after admission and at day of discharge
2. modified Rankin scale score at 3 months after stroke

Key secondary outcomes 1. outcome at hospital discharge
2. TIA, stroke recurrence, intracranial hemorrhage, cardiovascular event within 3 months after stroke

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dual antiplatelet group:
argatoroban, aspirin 100mg (day1 200mg), cropidogrel 75mg(day1 300mg) for 7 days, after day 7 mono antiplatelet agent
Interventions/Control_2 Mono antiplatelet group:
argatroban, aspirin 100mg (day1 200mg) for 7 days, after day 7 mono antiplatelet agent
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. non-cardioembolic stroke within 48 hours of onset
2. small vessel disease (lacunar or BAD (branch atheromatous disease))
3. NIHSS score below 20 points on admission
4. mRS score 0-2 before onset
5. patients written informed consent
Key exclusion criteria 1. cardioembolic stroke
2. antithrombotic therapy (cilostazol, ticlopidine, aspirin 100mg over, clopidogrel 75mg over, anticoagulants) before onset
3. congestive heart failure
4. medical history of allergies of argatroban, aspirin, clopidogrel
5. blood pressure cannot be controlled below 180/105mmHg
6. high hemorrhagic risk
7. severe stenosis of major cerebral and cervical artery
8. patients who are not appropriate to participate in this trial
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ryoji Nishi
Organization Okazaki City Hospital
Division name Department of Neurology
Zip code
Address 1-3 Gosyoai Kouryuji-cho Okazaki, Aichi
TEL 0564-21-8111
Email nishi-r@gc4.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ryoji Nishi
Organization Okazaki City Hospital
Division name Department of Neurology
Zip code
Address 1-3 Gosyoai Kouryuji-cho Okazaki, Aichi
TEL 0564-21-8111
Homepage URL
Email nishi-r@gc4.so-net.ne.jp

Sponsor
Institute Department of Neurology Okazaki City Hospital
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 岡崎市民病院(愛知県)

Other administrative information
Date of disclosure of the study information
2014 Year 06 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2013 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 12 Month 01 Day
Last follow-up date
2014 Year 12 Month 19 Day
Date of closure to data entry
2015 Year 01 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2014 Year 06 Month 27 Day
Last modified on
2016 Year 02 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016748

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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