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ROsuvastatin LOading and Clinical Outcomes Trial
NCT01936805Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2008
- Primary completion
- Jan 2012
- Countries
- 1
- Sponsor
- Türkiye Yüksek İhtisas Eğitim ve Araştırma Hastanesi
- Modality
- Orthosteric Ligands
- Drugs
- rosuvastatin
- Conditions
- ischemic heart disease (IHD)
01
Overview
Phase 3, randomised, double-blind trial of rosuvastatin in ischemic heart disease (IHD) (2 arms), sponsored by Türkiye Yüksek İhtisas Eğitim ve Araştırma Hastanesi. Primary endpoint: All cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke at 4 years. Started Jan 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Rosuvastatin
Rosuvastatin 40 mg loading dose
Control
Placebo loading dose
03
Who it enrols
Statin-naive patients with stable ischemic heart disease and de novo lesions appropriate for PCI. Patients with acute coronary syndromes or current statin use are excluded.
04
Endpoints
Primary
All cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke
Secondary
All cause death
Composite of death or myocardial infarction from CV causes, TVR, or stroke
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