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

October 18, 2010
January 3, 2013
October 2010
April 2011   (final data collection date for primary outcome measure)
Myocardial enzymes arise [ Time Frame: 12- 24 hours ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01228227 on ClinicalTrials.gov Archive Site
MACCE [ Time Frame: 1-6-12 Months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
ROsuvastatin Pretreatment to Reduce MyocArdial Periprocedural Necrosis:Comparison With Atorvastatin Reloading
High Loading ROsuvastatin Pretreatment in Patients Undergoing Elective PCI to Reduce the Incidence of MyocArdial Periprocedural Necrosis : Comparison With Atorvastatin High Dose Reloading.

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Assess the Periprocedural Myocardial Necrosis
  • Drug: ATORVASTATIN 80 mg
    reload of Atorvastatin 80 mg before the procedure
  • Drug: ROSUVASTATIN 40 mg
    reload of rosuvastatin 40 mg before the procedure
  • Active Comparator: ROSUVASTATIN
    Intervention: Drug: ROSUVASTATIN 40 mg
  • Experimental: ATORVASTATIN
    Intervention: Drug: ATORVASTATIN 80 mg
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
310
August 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

Patients with stable angina

Exclusion Criteria:

Baseline myocardial enzyme rise

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01228227
ROMA II
Yes
Gennaro Sardella, University of Roma La Sapienza
Gennaro Sardella
Not Provided
Not Provided
University of Roma La Sapienza
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP