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

Campus Bio-Medico University of Rome

Status and phase: Unknown; Phase 4

Conditions: Carotid Stenosis

Treatments: Drug: Clopidogrel; Drug: Atorvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01572623

2011-005330-18

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 50 to 90 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Antiplatelet before carotid artery stenting

Active Comparator group

Description:

Clopidogrel 600 mg after carotid artery stenting

Treatment:

Drug: Clopidogrel

Statin therapy before carotid artery stenting

Active Comparator group

Description:

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

Treatment:

Drug: Atorvastatin