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

G

Gennaro Sardella

Status and phase

Completed
Phase 3

Conditions

Assess the Periprocedural Myocardial Necrosis

Treatments

Drug: ROSUVASTATIN 40 mg
Drug: ATORVASTATIN 80 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT01228227
ROMA II

Details and patient eligibility

About

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.

Enrollment

310 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients with stable angina

Exclusion criteria

Baseline myocardial enzyme rise

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

310 participants in 2 patient groups

ROSUVASTATIN
Active Comparator group
Treatment:
Drug: ROSUVASTATIN 40 mg
ATORVASTATIN
Experimental group
Treatment:
Drug: ATORVASTATIN 80 mg

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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