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Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting (ARMYDA-CARO)

Primary Purpose

Carotid Stenosis

Status
Unknown status
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Clopidogrel
Atorvastatin
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Stenosis focused on measuring Therapeutic strategies for carotid artery stenting

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Campus Bio Medico University of RomeRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Antiplatelet before carotid artery stenting

Statin therapy before carotid artery stenting

Arm Description

Clopidogrel 600 mg after 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.

Outcomes

Primary Outcome Measures

Cerebral damage
Incidence of stroke at 30 days (defined as a neurologic deficit lasting> 24 hours with MRI evidence of cerebral ischemic injury) or transient ischemic attack (TIA); - Evidence of new onset acute ischemic lesions on MRI-DWI brain after the procedure, even in the absence of specific neurological symptoms

Secondary Outcome Measures

Bleeding complications
Effect on the 30-day major and minor bleeding (according to the TIMI definition); - Incidence of post-procedural vascular complications (pseudoaneurysm, AV fistula, hematoma> 5 cm).

Full Information

First Posted
April 4, 2012
Last Updated
April 5, 2012
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT01572623
Brief Title
Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting
Acronym
ARMYDA-CARO
Official Title
Efficacy of Two Different Pre-Intervention Therapeutic Strategies With Clopidogrel and Atorvastatin for the Prevention of Cerebral Damage During Carotid Artery Stenting. Armyda-Caro Randomized Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
September 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Stenosis
Keywords
Therapeutic strategies for carotid artery stenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Antiplatelet before carotid artery stenting
Arm Type
Active Comparator
Arm Description
Clopidogrel 600 mg after carotid artery stenting
Arm Title
Statin therapy before carotid artery stenting
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Clopidogrel
Intervention Description
Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.
Primary Outcome Measure Information:
Title
Cerebral damage
Description
Incidence of stroke at 30 days (defined as a neurologic deficit lasting> 24 hours with MRI evidence of cerebral ischemic injury) or transient ischemic attack (TIA); - Evidence of new onset acute ischemic lesions on MRI-DWI brain after the procedure, even in the absence of specific neurological symptoms
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Bleeding complications
Description
Effect on the 30-day major and minor bleeding (according to the TIMI definition); - Incidence of post-procedural vascular complications (pseudoaneurysm, AV fistula, hematoma> 5 cm).
Time Frame
30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Patti, MD
Phone
06225411899
Email
g.patti@unicampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patti Giuseppe, MD
Organizational Affiliation
Campus Bio-Medico University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Bio Medico University of Rome
City
Rome
State/Province
RM
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patti Giuseppe, MD
Phone
06225411899
Email
g.patti@unicampus.it
First Name & Middle Initial & Last Name & Degree
Melfi Rosetta, MD
First Name & Middle Initial & Last Name & Degree
Macrì Michele, MD
First Name & Middle Initial & Last Name & Degree
Picarelli Silvia, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23490041
Citation
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.
Results Reference
derived

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Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting

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