Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease. (Shield-CAD)

Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease. (Shield-CAD) - Study of high-dose Pitavastatin on lipid and glucose metabolism disorder in Coronary Artery Disease. (Shield-CAD)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000008627

Enrollment

100

Registered

2012-08-08

Start date

2012-06-01

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

Patients with stable coronary artery disease

Interventions

Administration of atorvastatin 10mg or rosuvastatin 2.5mg or pitavastatin 2mg in the first 3 months, followed by the administration of pitavastatin 4mg for 12 months.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Coronary artery disease patients Meeting one of following events 1) History of Acute Coronary Syndrome (AMI or Unstable angina) 2) History of revascularization (PCI or CABG) 3) Diagnosis of ischemic heart disease and coronary artery stenosis as having 75% or higher stenosis according to the AHA classification (2) Hypercholesterolemia patients Meeting one of following criteria 1) LDL-C is 100 mg/dL or over and requiring cholesterol lowering drugs judged by attending physicians 2) Patents receiving cholesterol lowering drugs (3) Age (20year old<=) (4) Patients given written informed consent.

Exclusion criteria

Exclusion criteria: Exclusion Criteria 1. Patients planed revascularization 2. Patients with occurrence of acute coronary syndrome (AMI or Unstable angina) within 3 months 3. Patients who have been undergone PCI or CABG within 3 months 4. Malignant tumor in active phase 5. Patients who have hypersensitivity to LIVALO, Lipitor, CRESTOR tablet 6) Patients who have severe liver dysfunction or biliary atresia. 7)Patients who are being treated with cyclosporine 8) Pregnant women, women suspected of being pregnant, or lactating women 9. Patients with prohibited drugs 10. Patients who received insulin therapy. 11. Patients who changed diabetes therapy within 3 months before entry. 12. Patients who received cholesterol-lowering agents except statin within a month before entry. 13. Patients undergoing dialysis 14. Patients with familial hypercholesterolemia 15. Patients who are ineligible in the opinion of the investigator

Design outcomes

Primary

Measure	Time frame
Change and percent change in HbA1c at 3, 6 months after administration	—

Secondary

Measure	Time frame
Change and percent change in TC, LDL-C, HDL-C, TG, Scr, microalbuminuria, eGFR, FBS, IRI, HOMA-IR, ApoA1, ApoB, ApoE and SAA at 3, 6, 9, 15 months after administration.	—

Countries

Japan

Contacts

Public ContactMiyakoshi Kazuho

Minami-Osaka Hospital Department of Cardiovascular Medicine

Outcome results

None listed

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