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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01572623
Recruitment Status : Unknown
Verified April 2012 by Patti Giuseppe, Campus Bio-Medico University.
Recruitment status was:  Recruiting
First Posted : April 6, 2012
Last Update Posted : April 6, 2012
Information provided by (Responsible Party):
Patti Giuseppe, Campus Bio-Medico University

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.

Condition or disease Intervention/treatment Phase
Carotid Stenosis Drug: Clopidogrel Drug: Atorvastatin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
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.
Study Start Date : July 2011
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01572623

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Contact: Giuseppe Patti, MD 06225411899

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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
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Principal Investigator: Patti Giuseppe, MD Campus Bio-Medico University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Patti Giuseppe, MD, Campus Bio-Medico University Identifier: NCT01572623     History of Changes
Other Study ID Numbers: 2011-005330-18
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012
Keywords provided by Patti Giuseppe, Campus Bio-Medico University:
Therapeutic strategies for carotid artery stenting
Additional relevant MeSH terms:
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Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
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