UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057329 |
|---|---|
| Receipt number | R000065404 |
| Scientific Title | Pharmacodynamic evaluation of antiplatelet therapy with aspirin and prasugrel by T-TAS and light transmittance aggregometry among patients undergoing percutaneous coronary intervention |
| Date of disclosure of the study information | 2025/03/18 |
| Last modified on | 2025/09/16 20:17:32 |
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Basic information
Public title
Pharmacodynamic evaluation of antiplatelet therapy with aspirin and prasugrel by T-TAS and light transmittance aggregometry among patients undergoing percutaneous coronary intervention
Acronym
PROVE study
Scientific Title
Pharmacodynamic evaluation of antiplatelet therapy with aspirin and prasugrel by T-TAS and light transmittance aggregometry among patients undergoing percutaneous coronary intervention
Scientific Title:Acronym
PROVE study
Region
| Japan |
Condition
Condition
coronary artery disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of prasugrel monotherapy on platelet aggregation compared with dual antiplatelet therapy with aspirin and prasugrel, and aspirin monotherapy.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Platelet-derived thrombogenicity (area under the flow-pressure curve for platelet chip (PL-AUC)) as assessed by total thrombus-formation analysis system (T-TAS).
Key secondary outcomes
Maximum platelet aggregation rate (MPR) measured by light transmission aggregometry (LTA) with ADP 20 microM and collagen 10 microM
PRU (P2Y12 reaction unit) and ARU (aspirin reaction unit) measured by VerifyNow
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients planned for percutaneous coronary intervention (PCI) and treated with dual antiplatelet therapy (DAPT) using aspirin and prasugrel
Key exclusion criteria
1.Patients unable to continue dual antiplatelet therapy (DAPT) for more than one month after PCI.
2.Patients currently taking non-steroidal anti-inflammatory drugs (NSAIDs).
3.Patients undergoing anticoagulation therapy (warfarin or novel anticoagulants).
4.Patients taking clopidogrel, cilostazol, or ticagrelor.
5.Patients with a platelet count of less than 100,000/microL at the time of enrollment.
6.Patients with hemoglobin levels less than 8 g/dL at the time of enrollment.
7.Patients with severe renal dysfunction (creatinine >= 2 mg/dL).
8.Patients who cannot provide informed consent.
9.Patients with a life expectancy of less than one year.
10.Patients judged by to be inappropriate as a research subject by investigators
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Ueki |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1,Asahi,Matsumoto,,Nagano
TEL
0263373486
yasushi522@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Itagaki |
Organization
Shinshu University Hospital
Division name
Department of Cardiovascular Medicine
Zip code
3900802
Address
3-1-1,Asahi,Matsumoto,,Nagano
TEL
0263373486
Homepage URL
itagaki@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Tadashi Itagaki
Funding Source
Organization
Fukuda Foundation for Medical Technology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University Hospital
Address
3-1-1,Asahi,Matsumoto,,Nagano
Tel
0263373486
itagaki@shinshu-u.ac.jp
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 | 03 | Month | 18 | 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
| 2025 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Single-center study
Non-intervention
Observational study
Management information
Registered date
| 2025 | Year | 03 | Month | 18 | Day |
Last modified on
| 2025 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065404
