UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Platelet aggregation evaluated with microchip flow-chamber system in patients with acute coronary syndromes.
Title of the study (Brief title)	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	Toshiki Asada
Organization	Yokohama Sakae Kyosai Hospital
Division name	Cardiology
Address	132 Katsura-cho, Sakae-ku, Yokohama
TEL	+81458912171
Email	toshiki_asada@hotmail.com

Public contact
Name of contact person	Toshiki Asada
Organization	Yokohama Sakae Kyosai Hospital
Division name	Cardiology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2015 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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