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Rosuvastatin in Preventing Myonecrosis in Elective Percutaneous Coronary Interventions (PCIs) (ROMA)

U

University of Roma La Sapienza

Status and phase

Completed
Phase 3

Conditions

Periprocedural Myocardial Necrosis

Treatments

Drug: ROSUVASTATIN

Study type

Interventional

Funder types

Other

Identifiers

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 copidogrel loading dose administration before procedure.(8,9 ) The investigators hypothesized that a high (40mg) loading dose of Rosuvastatin administered within 24h before the procedure may be effective in reducing the rate of periprocedural MI.Therefore, the investigators will conduct a single center,prospective randomized study to assess whether a single,high (40mg) loading (within24h)dose of Rosuvastatin is effective in preventing elevation of biomarkers of MI after elective coronary stent implantation.

Enrollment

160 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)

160 participants in 2 patient groups

CLOPIDOGREL
Active Comparator group
Treatment:
Drug: ROSUVASTATIN
ROSUVASTATIN
Experimental group
Treatment:
Drug: ROSUVASTATIN

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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