Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Patients with Coronary Artery Disease

Platelet Reactivity After Switching from Clopidogrel to Prasugrel in Patients with Coronary Artery Disease - Switching from Clopidogrel to Prasugrel

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000014528

Enrollment

Registered

2014-07-10

Start date

2014-07-03

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

Switching from Maintenance Clopidogrel to Prasgurel

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 for more than 14 days 3. Patients who are provided of the written agreement 4. Twenty to 80 years old 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. Weigh 50 kg or less 5. low platelet counts (less than 10*10^4) 6. Pregnant 7. Patients who are taking anticoagulants 8. Patients who are planned to administer thrombolytic agents 9. Patients scheduled for PCI or coronary artery bypass graft during this study 10. Patients who are taking ticlopidine or cilostazol 11. Patients judged as inappropriate for trial entry

Design outcomes

Primary

Measure	Time frame
The primary efficacy endpoint is the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose. We measure the platelet inhibition as the PRU from the VerifyNow P2Y12 platform assay with the predefined thresholds of PRU > 208 for HPR and PRU < 95 for LPR, respectively.	—

Secondary

Measure	Time frame
The secondary efficacy endpoints are the variation in the rate of high on-treatment platelet reactivity (HPR) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose and 2 weeks after switching again from prasugrel 3.75 mg to clopidogrel 75 mg, the difference of the mean PRU and mean inhibition rate between clopidogrel 75 mg and prasugrel 3.75 mg, the average value of the change of PRU, and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to TIMI bleeding 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) before and 2 weeks after switching from clopidogrel 75 mg maintenance dose to prasugrel 3.75 mg maintenance dose and 2 weeks after switching again from prasugrel 3.75 mg to clopidogrel 75 mg, the difference of the mean PRU and mean inhibition rate between clopidogrel 75 mg and prasugrel 3.75 mg, the average value of the change of PRU, and the relation between CYP2C19 polymorphism and platelet inhibition. The safety endpoints are the rate of bleeding events according to TIMI bleeding criteria, ischemic events, stent thrombosis, myocardial infarction during this study.

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Countries

Japan

Contacts

Public ContactTakeshi Nishi

Chiba University Hospital Department of Cardiovascular Medicine

takeshi24@hotmail.co.jp043-226-2340

Outcome results

None listed

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