NCT01646307

Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing PCI

Effect of Atorvastatin Versus Rosuvastatin Intensive Statin Regimens on Chinese Elderly Patients Undergoing Percutaneous Coronary Intervention

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: Beijing Anzhen Hospital · Academic / Other
• Sex: All
• Age: 65 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized, open label, parallel-group study is designed to investigate whether periprocedural intensive statin therapy with atorvastatin versus rosuvastatin administration before PCI and 30-day continuous intensive treatment is superior to usual care, in terms of cardiovascular events for Chinese elderly patients.

Detailed description

1800 elderly patients (\>65 yr) with coronary artery disease undergoing elective PCI were randomized in 2:1 fashion into either intensive statin group or standard care group. Patients in intensive statin group is further randomized into two subgroups: administrated with either atorvastatin 80mg 12h prior PCI, then 40mg 2h prior PCI, followed by 40 mg/d for 30 days after PCI; or rosuvastatin 20mg 12h prior PCI, then 10mg 2h prior PCI; followed by 10 mg/d for 30 days after PCI, while the standard care group receives atorvastatin 20 mg/d. After angiography, patients who are not undergoing PCI procedure will be excluded from the study as selection failure. The last visit will be at 6 months after PCI. Clinical data such as troponin, CK-MB, Scr, CCR, ALT, AST before and 24h to 48h after procedure will be recorded. 1000 eligible patients will be finally enrolled.The study will be conducted at 12 centers in China.

Conditions

• Focus of Study

Interventions

Type	Name	Description
DRUG	Atorvastatin
DRUG	Rosuvastatin

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-01-01
• Completion: 2013-06-01
• First posted: 2012-07-20
• Last updated: 2012-07-20

Locations

1 site across 1 country: China