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

This study is currently recruiting participants.
Verified April 2012 by Campus Bio-Medico University
Sponsor:
Information provided by (Responsible Party):
Patti Giuseppe, Campus Bio-Medico University
ClinicalTrials.gov Identifier:
NCT01572623
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: 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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Cerebral damage [ Time Frame: 30 days ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: Yes ]

    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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01572623

Contacts
Contact: Giuseppe Patti, MD 06225411899 g.patti@unicampus.it

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

No publications provided

Responsible Party: Patti Giuseppe, MD, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT01572623     History of Changes
Other Study ID Numbers: 2011-005330-18
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by 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
Clopidogrel
Ticlopidine
Atorvastatin
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
 Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites

ClinicalTrials.gov processed this record on May 16, 2013