Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI

Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI - Evaluation of the usefulness of new (dielectric) coagulometer (R) for monitoring of the efficacy of antiplatelet medicines among patients undergone elective PCI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000022548

Enrollment

Registered

2016-05-31

Start date

2016-08-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

effort angina pectoris or asymptomatic myocardial ischemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients who meet all of the following criteria are included in this study. 1. PCI is scheduled due to having effort angina pectoris or asymptomatic myocardial ischemia 2. Currently not on any antiplatelet medicines (excepting aspirin) 3. Patients who are at age of 20 or older when providing their written consent (both male and female) 4. Patients can give their consent in a written form

Exclusion criteria

Exclusion criteria: Patients who fall into any of the following criteria are excluded from participating in the study. 1. At high risks of bleeding 2. Have an experience of hypersensitivity to aspirin or prasugrel in the past 3. Currently pregnant, or possibly pregnant, or planning to be pregnant during the study 4. Had used P2Y12 inhibitor within two weeks before providing written consent 5. Have been prescribed with antiplatelets such as clopidogrel, cilostazol, sarpogrelate hydrochloride, etc. excluding aspirin 6. Currently on any anticoagulant, or planning to use an anticoagulant 7. Had joined other clinical study within the last month or currently being part of a clinical study, or planning to join other study while participating in this study 8. Other condition that the researcher thinks the participant is inappropriate to participate

Design outcomes

Primary

Measure	Time frame
Correlation between values of PRU and the coagulometer	—

Secondary

Measure	Time frame
1. Amount changed in coagulometer values 2. Subgroup analysis by the changed amount of coagulometer values 3. Correlation between coagulometer values and patients' background data 4. Subgroup analysis by coagulometer values 5. Safety of the study drugs (frequency of adverse events)	—

Countries

Japan

Contacts

Public ContactHiroki Takayama

Soiken Inc. Clinical Study Support Division

takayama@soiken.com03-3295-1350

Outcome results