Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention

Research on the efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine in patients undergoing percutaneous coronary intervention - The efficacy of LOTRIGA on coronary plaque formation and inflammatory cytokine

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000011371

Enrollment

Registered

2013-08-06

Start date

2013-09-30

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 undergoing percutaneous coronary intervention, complicated with dyslipidemia and who are treated with statins under at least six months or more

Interventions

Continuing statin Combined application of LOTRIGA 4g a day

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients in which stenosis is found to exceed 75% in 1-2 vessels, prompting implantation of a stent by percutaneous coronary intervention (PCI) 2)Age of patients is 20 years or older and less than 85 years 3)Patients of LDL cholesterol of 100 or less mg/dl, and who are treated with statin (under at least six months or more) 4)Patients who is possible to follow up for 6-8 months after PCI 5)Sex does not ask 6)Patients without the administration schedule of the supplement containing n-3 polyunsaturated fatty acid during exam time 7)Patients who have given written informed consent

Exclusion criteria

Exclusion criteria: 1)Patients with a past history of hypersensitivity to LOTRIGA 2)Patients suffering a stroke within the previous 6 months 3)Patients with a left vetricular ejection fraction of 40% or less 4)Patients on dialysis 5)Patients with bleeding (hemophilia, capilary fragility, gastrointestinal bleeding, urinary tract bleeding, hemoptysis, vitreous hemorrhaging etc.) 6)Patients with peptic ulcers 7)Patients considered unsuitable for other reasons

Design outcomes

Primary

Measure	Time frame
Evaluation of changes in plaque formation before and after medication by integrated backscatter intravascular ultrasound (IB-IVUS)	—

Secondary

Measure	Time frame
Changes in blood inflammation markers	—

Countries

Japan

Contacts

Public ContactKoji Yamaguchi

Tokushima university hospital Department of cardiovascular

Outcome results

None listed

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