Safety and eficity of 2.5mg prasugrel therapy in the eldely or low body weight Japanese patients undergoing percutaneous coronary intervention

Safety and eficity of 2.5mg prasugrel therapy in the eldely or low body weight Japanese patients undergoing percutaneous coronary intervention - 2.5mg Prasugrel therapy in the eldely or low body weight Japanese patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000019424

Enrollment

Registered

2015-10-21

Start date

2015-10-21

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

Ischemic Heart Disease

Interventions

Change from 3.75mg to 2.5mg Prasugrel Change from 2.5mg to 3.75mg Prasugrel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with ischemic heart disease who will undergo or have undergone percutaneous coronary intervention 2. Patients who are taking both aspirin and clopidogrel 3. Patients who are provided of the written agreement 4. Over 75 years old and/or less than 50kg 5. At least four weeks after an ACS event 6. Four weeks or more after PCI or coronary artery bypass graft

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to prasugrel 2. Patients who have severe liver problem 3. Patients who have severe kidney problem 4. History of stroke or transient ischemic attack 5. low platelet counts (less than 10*10^4) 6. Patients who are taking anticoagulants 7. Patients who are planned to administer thrombolytic agents 8. Patients scheduled for PCI or CABG during this study 9. Patients who are taking ticlopidine or cilostazol or prasugrel. 10. Patients judged as inappropriate for trial entry

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the variation in the rate of low on-treatment platelet reactivity (LPR) among Prasugrel 3.75 mg and prasugrel 2.5 mg maintenance dose. We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU < 95 for LPR	—

Secondary

Measure	Time frame
The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and optimal on treatment platlet reactivity (OPR) amomg clopidogrel 75 mg maintenance dose , prasugrel 3.75 mg maintenance dose and prasugrel 2.5mg maintenance dose, the difference of the mean PRU and mean inhibition rate, the average value of the change of PRU, the relation between coronary stent and platlet inhibition, the relation between date from InBody S20 and platelet inhibition and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to BARC criteria, ischemic events, stent thrombosis, myocardial infarction during this study.	—

Measure

Time frame

The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) and optimal on treatment platlet reactivity (OPR) amomg clopidogrel 75 mg maintenance dose , prasugrel 3.75 mg maintenance dose and prasugrel 2.5mg maintenance dose, the difference of the mean PRU and mean inhibition rate, the average value of the change of PRU, the relation between coronary stent and platlet inhibition, the relation between date from InBody S20 and platelet inhibition and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to BARC criteria, ischemic events, stent thrombosis, myocardial infarction during this study.

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Countries

Japan

Contacts

Public ContactShinichi Wakabayashi

Chiba University Hospital Department of Cardiovascular Medicine

worldpeacewaka@yahoo.co.jp043-226-2340

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026