Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Policlinico S. Donato

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

adult patients (age> 18 years)

patients 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 subjected to the treatment of carotid stenosis by stenting technique.

Disqualifiers

underage patients

patients who have not given their consent to participate in the study,

patients who have carotid stenosis not susceptible to intervention by stenting

pregnant or lactating women (such as situations in which carotid stenting is contraindicated regardless of the execution of the study).

Trial population

Patients who undergo carotid stenting for a significant carotid stenosis and who are treated with dual antiplatelet therapy using ASA + clopidogrel

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Clopidogrel

    Drug

    All patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel

  • Ticagrelor

    Drug

    All patients will undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel

Treatment groups

1,140 Participants
are divided into 2 treatment groups
Group A: Clopidogrel1 intervention
Group B: Ticagrelor1 intervention

Trial outcomes

Primary outcomes

1

Death

Outpatient visit

Time frame
1 month
2

Death

Outpatient visit

Time frame
3 months
3

MACE

Major Adverse Cardiovascular Events, Outpatient visit

Time frame
1 month
4

MACE

Major Adverse Cardiovascular Events, Outpatient visit

Time frame
3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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