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Double-blind Placebo-controlled Trial on the Effects of Statin prior to Percutaneous Coronary Interventions studied in Japanese subjects

Double-blind Placebo-controlled Trial on the Effects of Statin prior to Percutaneous Coronary Interventions studied in Japanese subjects - Pre-PCI Statin Effect Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000000576
Enrollment
100
Registered
2007-01-31
Start date
2007-01-01
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 Ischemic Heart Disease who will undergo PCI

Interventions

Following determination of lipid levels at baseline, rosuvastatin 5 mg will be given once daily for 7 days prior to PCI and 14 days after PCI regardless of baseline levels. Administration of lipid-low
100 mg/dL in accordance with the 2002 JAS Guidelines for the Diagnosis and Treatment of Arteriosclerotic Cardiovascular Diseases Following determination of lipid levels at baseline, a placebo will be
100 mg/dL in accordance with the 2002 JAS Guidelines for the Diagnosis and Treatment of Arteriosclerotic Cardiovascular Diseases

Sponsors

Department of Cardiovascular Medicine Kyushu University Faculty of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients untreated with statin for at least 2 weeks who will undergo PCI

Exclusion criteria

Exclusion criteria: Cases that requires emergent revascularization such as STEMI. Cases with grave complications such as pulmonary edema or cardiogenic shock. Cases with severe hyperlipidemia such as familial hypercholesterolemia who should be treated with statin. High risk cases for rhabdomyolysis such as hypothyroidism or taking fibrates. Pregnant or nursing female cases

Design outcomes

Primary

MeasureTime frame
Occurence of postprocedural increase of CK-MB >2 times above the upper normal limit or increase of troponin-T above the upper normal limit. Occurence of re-elevation of those factors as for cases with baseline elevation

Secondary

MeasureTime frame
Occurence of all major adverse cardiac events (death, acute myocardial infarction, unplanned cardiac catheterization a/o revascularization, hospitalization due to worsened angina) from the time of entry to 6 months of follow-up

Countries

Japan

Contacts

Public ContactKoji Todaka

Kyushu University Hospital Department of Cardiovascular Medicine

Outcome results

None listed

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