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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000024280
Receipt No. R000027969
Scientific Title Platelet aggregation evaluated with microchip flow-chamber system in patients with acute coronary syndromes.
Date of disclosure of the study information 2016/12/01
Last modified on 2016/10/04

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Basic information
Public title Platelet aggregation evaluated with microchip flow-chamber system in patients with acute coronary syndromes.
Acronym PLATE-ACS
Scientific Title Platelet aggregation evaluated with microchip flow-chamber system in patients with acute coronary syndromes.
Scientific Title:Acronym PLATE-ACS
Region
Japan

Condition
Condition Acute coronary syndromes
Classification by specialty
Cardiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We examined the platelet aggregation with prasugrel and clopidogrel for patients with ACS undergoing PCI, using a microchip flow-chamber system in the presence of collagen-surface and arterial shear flow rates.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes T10(time to 10kPa from baseline) and AUC10(area under the flow pressure curve for the first 10 min)
Key secondary outcomes MACE:Major Adverse Cardiovascular Events, and hemorrhage

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 NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients with ACS were randomly assigned to clopidogrel (loading/maintenance dose: 300/75 mg) or prasugrel (20/3.75 mg). Aspirin (200/100 mg) was administered in both groups. We evaluated the platelet aggregation at baseline, 0.5-1.0 hours, 2-4 hours, 6-12 hours and 18-24 hours after the loading dose, using T10 (time to reach 10 kPa from baseline) and AUC10 (area under the flow pressure curve for 10 min). T10 represented the onset of platelet thrombus formation and AUC10 represented total thrombogenicity.
Interventions/Control_2 Patients with ACS were randomly assigned to clopidogrel (loading/maintenance dose: 300/75 mg) or prasugrel (20/3.75 mg). Aspirin (200/100 mg) was administered in both groups. We evaluated the platelet aggregation at baseline, 0.5-1.0 hours, 2-4 hours, 6-12 hours and 18-24 hours after the loading dose, using T10 (time to reach 10 kPa from baseline) and AUC10 (area under the flow pressure curve for 10 min). T10 represented the onset of platelet thrombus formation and AUC10 represented total thrombogenicity.
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 Acute coronary syndromes; ST segment elevation myocardial infarction, non-ST elevation myocardial infarction and unstable angina pectoris
Key exclusion criteria 1. Indication for emergent CABG
2. Patients who are pregnant
3. Patients with past history of HIT
4. Other
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiki Asada
Organization Yokohama Sakae Kyosai Hospital
Division name Cardiology
Zip code
Address 132 Katsura-cho, Sakae-ku, Yokohama
TEL +81458912171
Email toshiki_asada@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Toshiki Asada
Organization Yokohama Sakae Kyosai Hospital
Division name Cardiology
Zip code
Address 132 Katsura-cho, Sakae-ku, Yokohama
TEL +81458912171
Homepage URL
Email toshiki_asada@hotmail.com

Sponsor
Institute The division of cardiology, Yokohama Sakae Kyosai Hospital
Institute
Department

Funding Source
Organization Yokohama Sakae Kyosai Hospital
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 10 Month 04 Day
Last modified on
2016 Year 10 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027969

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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