NCT02205775

Brief 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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started May 2010

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 31, 2014

Completed
Last Updated

July 31, 2014

Status Verified

February 1, 2011

Enrollment Period

1.8 years

First QC Date

July 30, 2014

Last Update Submit

July 30, 2014

Conditions

Stable Coronary Artery Disease Undergoing PCI

Outcome Measures

Primary Outcomes (1)

  • myocardial injury

    The proportion of patients with a post-procedural increase of any measured marker of myocardial injury (CK-MB, troponin I or troponin T) above upper normal limits, measured at any of the post-PCI determinations at up to 48 hours

    up to 48 hours

Secondary Outcomes (4)

  • Major adverse cardiac events

    1 month

  • Serum creatinine

    6, 24 and 48 h

  • HO-1

    6, 24 and 48 h

  • endothelial progenitor cells (EPCs)

    6, 24 and 48 h

Study Arms (4)

twice placebo before PCI

PLACEBO COMPARATOR
Drug: placebo

atorvastatin 80 + 40 mg pre PCI

EXPERIMENTAL
Drug: Atorvastatin

rosuvastatin 40 + 40 mg before PCI

EXPERIMENTAL
Drug: Rosuvastatin

rosuvastatin 5 + ezetimibe 10 mg twice before PCI

EXPERIMENTAL
Drug: RosuvastatinDrug: Ezetimibe

Interventions

AtorvastatinDRUG

80 + 40 mg pre PCI

atorvastatin 80 + 40 mg pre PCI
RosuvastatinDRUG

40 + 40 mg before PCI

rosuvastatin 40 + 40 mg before PCI
EzetimibeDRUG

10 mg twice before PCI (+ 5 mg rosuvastatin)

rosuvastatin 5 + ezetimibe 10 mg twice before PCI
placeboDRUG

twice before PCI

twice placebo before PCI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- suspected CAD for which an indication to PCI is given: both patients with stable CAD, and stable post-acute coronary syndromes (ACS), both with ST-segment elevation (STEMI) and without ST-segment elevation (NSTE-ACS) patients, provided that markers of myocardial necrosis (CK-MB, troponins) are stabilized (i.e., with variations \<20% in two consecutive measurements obtained at ≥6 h time distance before PCI, according to the universal definition of peri-procedural myocardial infarction).

You may not qualify if:

  • any previously known increase in liver enzymes (AST, ALT) ascribed to liver dysfunction at baseline;
  • history of liver toxicity or myopathy on previous treatment with statins;
  • left ventricular ejection fraction \<30%;
  • renal insufficiency, with creatinine \>2 mg/dL at baseline;
  • ongoing treatment with high-dose statins (atorvastatin 80 mg/d or rosuvastatin 40 mg/d);
  • pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

SS. Annunziata Hospital

Chieti, CH, 66100, Italy

Location

Fondazione IRCCS Policlinico S. Matteo

Pavia, PV, 27100, Italy

Location

A.O. S. Anna e S. Sebastiano - II Università di Napoli

Caserta, 81100, Italy

Location

Azienda ASL 6 - P. Ospedaliero Livorno

Livorno, 57100, Italy

Location

Ospedale Civile G. Fornaroli

Magenta, 20013, Italy

Location

Azienda Ospedaliera - Ospedale San Paolo

Milan, 20142, Italy

Location

MeSH Terms

Interventions

AtorvastatinRosuvastatin CalciumEzetimibe

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipidsSulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesAzetidinesAzetines

Study Officials

  • Raffaele De Caterina, Prof

    Università G. d'Annunzio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Director - Institute of Cardiology

Study Record Dates

First Submitted

July 30, 2014

First Posted

July 31, 2014

Study Start

May 1, 2010

Primary Completion

March 1, 2012

Study Completion

June 1, 2012

Last Updated

July 31, 2014

Record last verified: 2011-02

Locations

IT(6)