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ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading (ROMAIIReload)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gennaro Sardella, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01228227
First received: October 18, 2010
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

An increase in cardiac biomarkers has been shown to occur in 5% to 30% of patients after otherwise successful percutaneous coronary interventions (PCIs)(1) Apart from side-branch occlusion, intimal dissection and coronary spasm, a possible aetiology of myonecrosis after PCI might be distal embolization of atherogenic materials from plaque disruption,(2 )causing obstruction of blood flow at capillary level resulting in micro-infarction.(3,4 )Recent studies have suggested that pretreatment with Atorvastatin may be associated with a reduction in infarct size after elective PCI. (5-7 ). Actually the standard pretreatment in patients undergoing elective coronary-PCI and already treated with aspirin is clopidogrel loading dose administration before procedure.(8,9)The investigators compared a high (80mg) re-loading dose of Atorvastatin with a high loading dose of Rosuvastatin (40 mg) both administered within 24h before the procedure in reducing the rate of periprocedural MI. Therefore, the investigators will conduct a single center, prospective randomized study to assess whether a single, high (80mg) loading (within 24h)dose of Atorvastatin compared with a single loading dose of Rosuvastatin (20 mg) is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation. We evaluate the incidence of MACCE(occurring of cardiac death, myocardial infarction (including periprocedural myonecrosis) and stroke at 30 days 6 and 12 month follow-up.


Condition Intervention Phase
Assess the Periprocedural Myocardial Necrosis
 Drug: ATORVASTATIN 80 mg
Drug: ROSUVASTATIN 40 mg
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.

Resource links provided by NLM:

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Further study details as provided by University of Roma La Sapienza:

Primary Outcome Measures:
  • Myocardial enzymes arise [ Time Frame: 12- 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • MACCE [ Time Frame: 1-6-12 Months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 310
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: ROSUVASTATIN Drug: ROSUVASTATIN 40 mg
reload of rosuvastatin 40 mg before the procedure
Experimental: ATORVASTATIN Drug: ATORVASTATIN 80 mg
reload of Atorvastatin 80 mg before the procedure

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with stable angina

Exclusion Criteria:

Baseline myocardial enzyme rise

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228227

Locations
Italy
Policlinico Umberto I
Roma, Italy
Sponsors and Collaborators
Gennaro Sardella
  More Information

No publications provided

Responsible Party: Gennaro Sardella, Associate Professor in Cardiology, University of Roma La Sapienza
ClinicalTrials.gov Identifier: NCT01228227     History of Changes
Other Study ID Numbers: ROMA II
Study First Received: October 18, 2010
Last Updated: January 3, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Roma La Sapienza:
Myonecrosis
Percutaneous Angioplasty
Myocardial Infarction

Additional relevant MeSH terms:
Myocardial Infarction
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Pathologic Processes
Atorvastatin
Rosuvastatin
 Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013