Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting

Carotid Stenosis Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01572623
• Other study ID #: 2011-005330-18
• Status: Recruiting
• Phase: Phase 4
• First received: April 4, 2012
• Last updated: April 5, 2012
• Start date: July 2011
• Est. completion date: September 2012

Study information

• Verified date: April 2012
• Source: Campus Bio-Medico University
• Contact: Giuseppe Patti, MD
• Phone: 06225411899
• Email: g.patti[@]unicampus.it
• Is FDA regulated: No
• Health authority: Italy: The Italian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Carotid Stenosis

Intervention

Drug:
• Clopidogrel
Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting
• Atorvastatin
Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.

Locations

Country	Name	City	State
Italy	Campus Bio Medico University of Rome	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days	No
Secondary	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).	30 days	Yes