FindTrial
Sign In

Research on the efficacy of eicosapentaenoic acid (EPA) on coronary plaque formation in patients undergoing percutaneous coronary intervention.

Research on the efficacy of eicosapentaenoic acid (EPA) on coronary plaque formation in patients undergoing percutaneous coronary intervention. - ReSPECT-Study Reduction of Soft Plaque by EPA, Clinical Tokushima Study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000002059
Enrollment
40
Registered
2009-06-20
Start date
2009-05-01
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

Patients underdoing percutaneous coronary intervention complicated with dyslipidemia.

Interventions

Intervention 1: Atrovastatin (Lipitor: 5 mg, 10 mg), pitavastatin (Livalo: 1 mg, 2 mg) or rosuvastatin (Crestol: 2.5 mg, 5 mg) Combined application of high-purity EPA preparation (Epadel 1,800 mg) wit

Sponsors

Cardiovascular Medicine. The University of Tokushima Institute of Health Biosciences, Graduate School.
Lead Sponsor

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 bare-metal stent (BMS) by percutaneous coronary intervention (PCI). 2) Patients with LDL cholesterol 160 mg/dl or above, patients having taken strong statin, or mild statin with LDL cholesterol 100 mg/dl or above.

Exclusion criteria

Exclusion criteria: 1. Patients with a past history of hypersensitivity to high-purity EPA preparations. 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

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

Secondary

MeasureTime frame
1.Changes in blood inflammation and coagulation markers hs-CRP IL-6 TNF-alpha IP-10 MMP-3 MMP-9 PTX3 Heparin cofactor 2 2.Blood EPA/AA ratio 3.Vascular endothelial function (flow-mediated dilatation; FMD)—

Countries

Japan

Outcome results

None listed

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