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

NCT ID: NCT01007279

Last Updated: 2010-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2010-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Periprocedural Myocardial Necrosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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CLOPIDOGREL

Group Type ACTIVE_COMPARATOR

ROSUVASTATIN

Intervention Type DRUG

40 mg before procedure

ROSUVASTATIN

Group Type EXPERIMENTAL

ROSUVASTATIN

Intervention Type DRUG

40 mg before procedure

Interventions

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ROSUVASTATIN

40 mg before procedure

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with stable angina

Exclusion Criteria

* Baseline myocardial enzyme rise
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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POLICLINICO UMBERTO I-SAPIENZA UNIVERSITY OF ROME

Locations

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Policlinico Umberto I

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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ROMA55

Identifier Type: -

Identifier Source: org_study_id