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ROsuvastatin LOading and Clinical Outcomes Trial

NCT ID: NCT01936805

Last Updated: 2013-09-06

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

299 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2012-01-31

Brief Summary

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The aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke.

Detailed Description

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Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Rosuvastatin

A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Group Type ACTIVE_COMPARATOR

Rosuvastatin

Intervention Type DRUG

A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Control

A loading dose of placebo was administrated 24 h before the PCI.

Group Type PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

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Rosuvastatin

A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* statin-naive patients
* stable ischemic heart disease
* de novo lesions appropriate for PCI

Exclusion Criteria

* current statin use
* statin allergic patients
* acute coronary syndromes
* lesions not appropriate for PCI
* refusal for participation
* statin quitting during follow- up
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuksek Ihtisas Hospital

OTHER

Sponsor Role lead

Responsible Party

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Serkan Cay

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Yuksek Ihtisas Hospital

Ankara, Altindag, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2173862

Identifier Type: -

Identifier Source: org_study_id