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

UMIN ID: UMIN000002059

Registered date:20/06/2009

Basic Information

• Health condition(s) or Problem(s) studied: Patients underdoing percutaneous coronary intervention complicated with dyslipidemia.
• Date of first enrollment: 2009/05/01
• Target sample size: 40
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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) with intervention 1.

Outcome(s)

• Primary Outcome: Evaluation of changes in plaque formation before and after medication by integrated backscatter intravascular ultrasound (IB-IVUS).
• Secondary Outcome: 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)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 85years-old
• Gender: Male and Female
• Exclude 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.

Related Information

• Primary Sponsor: Cardiovascular Medicine. The University of Tokushima Institute of Health Biosciences, Graduate School.
• Source(s) of Monetary Support: None