UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024280 |
|---|---|
| Receipt number | 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 12:41:50 |
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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
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
toshiki_asada@hotmail.com
Sponsor or person
Institute
The division of cardiology, Yokohama Sakae Kyosai Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027969
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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