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Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty (REMEDY)

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ClinicalTrials.gov Identifier: NCT02205775
Recruitment Status : Terminated (difficult recruitment)
First Posted : July 31, 2014
Last Update Posted : July 31, 2014
Sponsor:
Collaborator:
Working Group Aterosclerosi, Trombosi e Biologia Vascolare
Information provided by (Responsible Party):
Raffaele De Caterina, G. d'Annunzio University

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.


Condition or disease Intervention/treatment Phase
Stable Coronary Artery Disease Undergoing PCI Drug: Atorvastatin Drug: Rosuvastatin Drug: Ezetimibe Drug: placebo Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 280 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Rosuvastatin for Reduction of Myocardial Damage and Systemic Inflammation During Coronary Angioplasty - The REMEDY Study
Study Start Date : May 2010
Actual Primary Completion Date : March 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty

Arm Intervention/treatment
Placebo Comparator: twice placebo before PCI Drug: placebo
twice before PCI

Experimental: atorvastatin 80 + 40 mg pre PCI Drug: Atorvastatin
80 + 40 mg pre PCI

Experimental: rosuvastatin 40 + 40 mg before PCI Drug: Rosuvastatin
40 + 40 mg before PCI

Experimental: rosuvastatin 5 + ezetimibe 10 mg twice before PCI Drug: Rosuvastatin
5 mg twice before PCI (+ 10 mg ezetimibe)

Drug: Ezetimibe
10 mg twice before PCI (+ 5 mg rosuvastatin)




Primary Outcome Measures :
  1. myocardial injury [ Time Frame: up to 48 hours ]
    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


Secondary Outcome Measures :
  1. Major adverse cardiac events [ Time Frame: 1 month ]
    The combined occurrence of major adverse cardiac events (MACE), including death, myocardial infarction, stroke or the need for unplanned revascularization from the time of the procedure until the end of a 1-month follow-up.

  2. Serum creatinine [ Time Frame: 6, 24 and 48 h ]
    Any post-procedural increase in serum creatinine or decrease in creatinine clearance (Cockcroft-Gault formula)

  3. HO-1 [ Time Frame: 6, 24 and 48 h ]
    Changes in HO-1 levels/biologic activity among treated groups(only for sites participating in the specific substudies)

  4. endothelial progenitor cells (EPCs) [ Time Frame: 6, 24 and 48 h ]
    Changes in EPC levels/biologic activity among treated groups (only for sites participating in the specific substudies)



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02205775


Locations
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Italy
SS. Annunziata Hospital
Chieti, CH, Italy, 66100
Fondazione IRCCS Policlinico S. Matteo
Pavia, PV, Italy, 27100
A.O. S. Anna e S. Sebastiano - II Università di Napoli
Caserta, Italy, 81100
Azienda ASL 6 - P. Ospedaliero Livorno
Livorno, Italy, 57100
Ospedale Civile G. Fornaroli
Magenta, Italy, 20013
Azienda Ospedaliera - Ospedale San Paolo
Milano, Italy, 20142
Sponsors and Collaborators
G. d'Annunzio University
Working Group Aterosclerosi, Trombosi e Biologia Vascolare
Investigators
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Principal Investigator: Raffaele De Caterina, Prof Università G. d'Annunzio

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Responsible Party: Raffaele De Caterina, Professor, Director - Institute of Cardiology, G. d'Annunzio University
ClinicalTrials.gov Identifier: NCT02205775     History of Changes
Other Study ID Numbers: 2009-013622-17
First Posted: July 31, 2014    Key Record Dates
Last Update Posted: July 31, 2014
Last Verified: February 2011
Additional relevant MeSH terms:
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Coronary Artery Disease
Inflammation
Pathologic Processes
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Atorvastatin
Rosuvastatin Calcium
Ezetimibe
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors