Comparison of clopidogrel and prasugrel as prophylaxis for In-stent protrusion evaluated by optical coherence tomography in patients with ST-segment elevation myocardial infarction

Comparison of clopidogrel and prasugrel as prophylaxis for In-stent protrusion evaluated by optical coherence tomography in patients with ST-segment elevation myocardial infarction - INSPECT-MI

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017732

Enrollment

Registered

2015-05-29

Start date

2015-06-01

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

ST-segment elevation myocardial infarction

Interventions

Patients were randomly assigned by computer-generated randomization sequence to receive prasugrel. Prasugrel treatment was started with a loading dose of 20mg orally before stent implantation, followe

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with ST-segment elevation myocardial infarction (STEMI) within 12 hours from symptom onset who are scheduled to undergo coronary stent implantation are enrolled.

Exclusion criteria

Exclusion criteria: (1)Use of oral anticoagulants, ticlodipine, cilostazol and clopidogrel (2)Cardiopulmonary arrest or prolonged CPR (3)Cardiogenic shock (4)STEMI caused by coronary artery bypass graft disease or in-stent restenosis (5)Unsuitable for stent implantation (6)Severe chronic renal failure with serum creatinine >2mg/dL (7)Left main trunk disease (8) Serum hemoglobin level < 9g/dL or >18g/dL Platelet count < 50,000 /mm3 or > 500,000 /mm3 (9) Hematologic or malignant disorder with the life expectancy < 1 year (10)Major bleeding events within 7 days before enrollment (11) Severe liver dysfunction (hepatic cirrhosis or portal hypertension) (12)Drug allergy to aspirin, clopidogrel or prasugrel (13)Women of pregnant, childbearing potential or lactation (14)Participating in the other trial (phase 1-3) (15)Patients who are not allowed to participate in the trial by judgement of the treating physician

Design outcomes

Primary

Measure	Time frame
In-stent protrusion volume with stent-length correction, evaluated by OCT 14 days after primary PCI	—

Secondary

Measure	Time frame
Median variation of in-stent protrusion volume evaluated by OCT Median PRU value (or % inhibition) assessed with VerifyNow-P2Y12 assay 1 hour after a loading dose of prasugrel or clopidogrel * Median variation of PRU value (or % inhibition) using with VerifyNow-P2Y12 assay during treatment period * Median variation of AUC (or occlusion time) evaluated with T-TAS system during treatment period * Frequency of 30-day adverse cardiovascular events (including all-cause death, re-infarction, heart failure, target vessel revascularization, stent thrombosis)	—

Measure

Time frame

*Median variation of in-stent protrusion volume evaluated by OCT * Median PRU value (or % inhibition) assessed with VerifyNow-P2Y12 assay 1 hour after a loading dose of prasugrel or clopidogrel * Median variation of PRU value (or % inhibition) using with VerifyNow-P2Y12 assay during treatment period * Median variation of AUC (or occlusion time) evaluated with T-TAS system during treatment period * Frequency of 30-day adverse cardiovascular events (including all-cause death, re-infarction, heart failure, target vessel revascularization, stent thrombosis)

—

Countries

Japan

Contacts

Public ContactKengo Tsukahara

Yokohama city university medical center Cardiovascular center

k-tsuka@urahp.yokohama-cu.ac.jp045-261-5656

Outcome results

None listed

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