NCT01572623

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

Enrollment Period

1.2 years

First QC Date

April 4, 2012

Last Update Submit

April 5, 2012

Conditions

Carotid Stenosis

Keywords

Therapeutic strategies for carotid artery stenting

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Bleeding complications

    30 days

Study Arms (2)

Antiplatelet before carotid artery stenting

ACTIVE COMPARATOR

Clopidogrel 600 mg after carotid artery stenting

Drug: Clopidogrel

Statin therapy before carotid artery stenting

ACTIVE COMPARATOR

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

Interventions

ClopidogrelDRUG

Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting

Antiplatelet before carotid artery stenting
AtorvastatinDRUG

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

Statin therapy before carotid artery stenting

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • symptomatic and asymptomatic patients with finding of significant carotid stenosis

You may not qualify if:

  • patients with acute injuries to the baseline MRI of the brain,
  • patients with active bleeding,
  • contraindications to statin therapy and MRI contraindications (pacemaker/claustrophobic).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campus Bio Medico University of Rome

Rome, RM, 00128, Italy

RECRUITING

Related Publications (1)

  • Patti G, Tomai F, Melfi R, Ricottini E, Macri M, Sedati P, Giardina A, Aurigemma C, Leporace M, D'Ambrosio A, Di Sciascio G. Strategies of clopidogrel load and atorvastatin reload to prevent ischemic cerebral events in patients undergoing protected carotid stenting. Results of the randomized ARMYDA-9 CAROTID (Clopidogrel and Atorvastatin Treatment During Carotid Artery Stenting) study. J Am Coll Cardiol. 2013 Apr 2;61(13):1379-87. doi: 10.1016/j.jacc.2013.01.015. Epub 2013 Mar 9.

    PMID: 23490041DERIVED

MeSH Terms

Conditions

Carotid Stenosis

Interventions

ClopidogrelAtorvastatin

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingPyrrolesAzolesHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Patti Giuseppe, MD

    Campus Bio-Medico University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Patti, MD

CONTACT

06225411899g.patti@unicampus.it

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 6, 2012

Study Start

July 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

IT(1)