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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2012 by Patti Giuseppe, Campus Bio-Medico University.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Patti Giuseppe, Campus Bio-Medico University Identifier:
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
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.

Condition Intervention Phase
Carotid Stenosis Drug: Clopidogrel Drug: Atorvastatin Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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.

Resource links provided by NLM:

Further study details as provided by Patti Giuseppe, Campus Bio-Medico University:

Primary Outcome Measures:
  • Cerebral damage [ Time Frame: 30 days ]

    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 [ Time Frame: 30 days ]

    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).

Estimated Enrollment: 150
Study Start Date: July 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Antiplatelet before carotid artery stenting
Clopidogrel 600 mg after carotid artery stenting
Drug: Clopidogrel
Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting
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
Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.


Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).
  Contacts and Locations
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Please refer to this study by its identifier: NCT01572623

Contact: Giuseppe Patti, MD 06225411899

Campus Bio Medico University of Rome Recruiting
Rome, RM, Italy, 00128
Contact: Patti Giuseppe, MD    06225411899   
Sub-Investigator: Melfi Rosetta, MD         
Sub-Investigator: Macrì Michele, MD         
Sub-Investigator: Picarelli Silvia, MD         
Sponsors and Collaborators
Campus Bio-Medico University
Principal Investigator: Patti Giuseppe, MD Campus Bio-Medico University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Patti Giuseppe, MD, Campus Bio-Medico University Identifier: NCT01572623     History of Changes
Other Study ID Numbers: 2011-005330-18
Study First Received: April 4, 2012
Last Updated: April 5, 2012

Keywords provided by Patti Giuseppe, Campus Bio-Medico University:
Therapeutic strategies for carotid artery stenting

Additional relevant MeSH terms:
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors processed this record on September 21, 2017