Regulated Optical coherence tomography Follow-ups for Thrombus Evaluation-01 (ROUTE-01) study

Regulated Optical coherence tomography Follow-ups for Thrombus Evaluation-01 (ROUTE-01) study - ROUTE-01 study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000017131

Enrollment

250

Registered

2015-04-14

Start date

2015-10-17

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

patients with coronary artery disease referred for PCI under treatment with prasugrel 3.75mg/day

Interventions

Optical coherence tomography (OCT) was performed for the stented vessel at index PCI and 9 months after stent implantation under prescription of prasugrel

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: patients with coronary artery disease (including ACS) referred for PCI under treatment with prasugrel 3.75mg/day

Exclusion criteria

Exclusion criteria: 1.patient treated with warfarin or novel oral anticoagulants (NOAC) 2.patient treated with other antiplatelet therapy 3.planning an invasive treatment with high bleeding risk 4.contraindication of aspirin or prasugrel

Design outcomes

Primary

Measure	Time frame
the frequency of in-stent thrombus assessed by follow-up OCT 9 months after stent implantation	—

Secondary

Measure	Time frame
NIT and % of uncovered stent struts assessed by follow-up OCT 9 months after stent implantation Major adverse cardiovascular and cerebral events (MACCE) Bleeding complications	—

Countries

Japan

Contacts

Public ContactToshiro Shinke

Kobe University Graduate School of Medicine Division of Cardiovascular Medicine, Department of Internal Medicine

shinke@med-showa-u.ac.jp078-382-5111

Outcome results

None listed

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