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Status unknownNCT01572623ARMYDA-CAROUpdated Apr 6, 2012

Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting

A Phase 4 interventional study of Clopidogrel and Atorvastatin in Carotid Stenosis, sponsored by Campus Bio-Medico University. Status unknown at 1 site in Italy. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-04-06.

Sponsored by Campus Bio-Medico University · Phase 4, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Apr 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
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Study 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.

02

Conditions studied

  • Carotid Stenosis

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Keywords

  • Therapeutic strategies for carotid artery stenting
03

In context

Carotid Stenosis

339 studies on the registry are indexed under Carotid Stenosis; 81 are open to participants now.

This study's planned enrollment of 150 is above the median of 106 across 182 interventional studies indexed under Carotid Stenosis.

Browse Carotid Stenosis studies →

Lead sponsor

Campus Bio-Medico University is the lead sponsor of 82 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • symptomatic and asymptomatic patients with finding of significant carotid stenosis

Exclusion criteria

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).
05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    Antiplatelet before carotid artery stenting

    Clopidogrel 600 mg after carotid artery stenting

    Drug: Clopidogrel

  • Active comparator
    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.

    Drug: Atorvastatin

Interventions

  • DrugClopidogrel

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

  • DrugAtorvastatin

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 30 days

Secondary outcomes

  1. 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).

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
  • Campus Bio Medico University of Rome
    Rome, RM 00128, Italy
    • Patti Giuseppe, MD · Contact · g.patti@unicampus.it · 06225411899
    • Melfi Rosetta, MD · Sub investigator
    • Macrì Michele, MD · Sub investigator
    • Picarelli Silvia, MD · Sub investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23490041 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01572623
Lead sponsor
Campus Bio-Medico University
Responsible party
Patti Giuseppe (MD, Campus Bio-Medico University) — Principal investigator
First posted
Apr 6, 2012
Start date
Jul 2011
Primary completion
Sep 2012 (estimated)
Completion
Sep 2012 (estimated)
Last update
Apr 6, 2012

Study contacts

Giuseppe Patti, MD
Contact
g.patti@unicampus.it
06225411899
Patti Giuseppe, MD
principal investigator · Campus Bio-Medico University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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