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

No results posted yet for this study

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

Atorvastatin

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

placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02205775 on ClinicalTrials.gov