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

UMIN ID: UMIN000000576

Registered date:31/01/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with Ischemic Heart Disease who will undergo PCI
• Date of first enrollment: 2007/01/01
• Target sample size: 100
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

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-lowering agents other than statin is allowed for the treatment of hyperlipidemia if the investigator judges it necessary during the treatment with the study drug. After completion of the treatment with the study drug, medication for hyperlipidemia including statin will be given to let patients achieve the guideline target of LDL-C <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 given once daily for 7 days prior to PCI and 14 days after PCI regardless of baseline levels. Administration of lipid-lowering agents other than statin is allowed for the treatment of hyperlipidemia if the investigator judges it necessary during the treatment with the study drug. After completion of the treatment with the study drug, medication for hyperlipidemia including statin will be given to let patients achieve the guideline target of LDL-C <100 mg/dL in accordance with the 2002 JAS Guidelines for the Diagnosis and Treatment of Arteriosclerotic Cardiovascular Diseases

Outcome(s)

• Primary Outcome: 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 Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude 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

Related Information

• Primary Sponsor: Department of Cardiovascular Medicine Kyushu University Faculty of Medicine
• Source(s) of Monetary Support: Japan Society for the Promotion of Science