Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty
NCT02205775 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 280
Last updated 2014-07-31
Summary
Myocardial necrosis is relatively frequent after percutaneous coronary intervention and is associated with higher mortality during the follow-up.
Since anti-inflammatory properties of statins have been demonstrated and the benefit of statins in acute coronary syndromes have been proven, this study aims at testing the hypothesis that the pre-procedural intensive statin treatment reduce the extent of peri-procedural necrosis.
Conditions
- Stable Coronary Artery Disease Undergoing PCI
Interventions
- DRUG
-
80 + 40 mg pre PCI
- DRUG
-
Rosuvastatin
40 + 40 mg before PCI
- DRUG
-
Rosuvastatin
5 mg twice before PCI (+ 10 mg ezetimibe)
- DRUG
-
Ezetimibe
10 mg twice before PCI (+ 5 mg rosuvastatin)
- DRUG
-
twice before PCI
Sponsors & Collaborators
-
Working Group Aterosclerosi, Trombosi e Biologia Vascolare
collaborator UNKNOWN -
G. d'Annunzio University
lead OTHER
Principal Investigators
-
Raffaele De Caterina, Prof · Università G. d'Annunzio
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-05-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-06-30
Countries
- Italy
Study Locations
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