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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05566301
Other study ID # MULTI-RESCLOSA v.1 16-2-21
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date September 2, 2021
Est. completion date December 31, 2026

Study information

Verified date December 2023
Source IRCCS Policlinico S. Donato
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Spontaneous prospective observational multicentre pharmacological study that aims to evaluate whether, from a statistical point of view, there is a significant difference between the use of Ticagrelor in "non-responders" patients to Clopidogrel undergoing carotid stenting and Clopidogrel in "responders" undergoing carotid stenting, in the onset of death and major adverse cardiovascular events (MACE) and bleeding events, 1 and 3 months after the procedure. Furthermore, the study aims to evaluate the possible preoperative clinical and pharmacological factors most associated with the phenomenon of resistance to Clopidogrel. Inclusion criteria: The data will be collected on adult patients (age> 18 years) who have given their consent to participate in the study, belonging to the U.O. of Vascular Surgery of the IRCCS Policlinico San Donato and the U.O. of Vascular Surgery of the participating centers and there subjected to the treatment of carotid stenosis by stenting technique. Exclusion criteria: Those patients who are minors, who have not given their consent to participate in the study, or who have carotid stenosis not susceptible to intervention by stenting will be excluded from the study. Pregnant or lactating women will also be excluded from the study (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Clopidogrel
All patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel
Ticagrelor
All patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel

Locations

Country Name City State
Italy IRCCS Policlinico San Donato San Donato Milanese Milan

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Policlinico S. Donato

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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Outcome

Type Measure Description Time frame Safety issue
Primary Death Outpatient visit 1 month
Primary Death Outpatient visit 3 months
Primary MACE Major Adverse Cardiovascular Events, Outpatient visit 1 month
Primary MACE Major Adverse Cardiovascular Events, Outpatient visit 3 months
Primary Occurrence of major hemorrhagic events Outpatient visit 1 month
Primary Occurrence of major hemorrhagic events Outpatient visit 3 months
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