Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting

NCT ID: NCT01572623

Last Updated: 2012-04-06

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-09-30

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of two different loading doses of Clopidogrel and a reloading of Atorvastatin in the prevention of periprocedural ischemic brain damage in patients undergoing carotid angioplasty.

Detailed Description

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Conditions

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Carotid Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Antiplatelet before carotid artery stenting

Clopidogrel 600 mg after carotid artery stenting

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting

Statin therapy before carotid artery stenting

Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.

Interventions

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Clopidogrel

Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting

Intervention Type DRUG

Atorvastatin

Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* symptomatic and asymptomatic patients with finding of significant carotid stenosis

Exclusion Criteria

* patients with acute injuries to the baseline MRI of the brain,
* patients with active bleeding,
* contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Campus Bio-Medico University

OTHER

Sponsor Role lead

Responsible Party

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Patti Giuseppe

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Patti Giuseppe, MD

Role: PRINCIPAL_INVESTIGATOR

Campus Bio-Medico University

Locations

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Campus Bio Medico University of Rome

Rome, RM, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Giuseppe Patti, MD

Role: CONTACT

06225411899

Facility Contacts

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Patti Giuseppe, MD

Role: primary

06225411899

References

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Patti G, Tomai F, Melfi R, Ricottini E, Macri M, Sedati P, Giardina A, Aurigemma C, Leporace M, D'Ambrosio A, Di Sciascio G. Strategies of clopidogrel load and atorvastatin reload to prevent ischemic cerebral events in patients undergoing protected carotid stenting. Results of the randomized ARMYDA-9 CAROTID (Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting) study. J Am Coll Cardiol. 2013 Apr 2;61(13):1379-87. doi: 10.1016/j.jacc.2013.01.015. Epub 2013 Mar 9.

Reference Type DERIVED
PMID: 23490041 (View on PubMed)

Other Identifiers

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2011-005330-18

Identifier Type: -

Identifier Source: org_study_id

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