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

NCT05566301 | Recruiting FDA Drug

• 1 other identifier: MULTI-RESCLOSA v.1 16-2-21
• Study Type: observational
• Target: 1,140
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Clopidogrel, Poor Metabolism of; Carotid Stenosis

Keywords

clopidogrel resistance; carotid artery stenting; carotid stenosis; dual antiplatelet therapy; ticagrelor

Outcome Measures

Primary Outcomes (6)

• Death

  Outpatient visit

  1 month

• Death

  Outpatient visit

  3 months

• MACE

  Major Adverse Cardiovascular Events, Outpatient visit

  1 month

• MACE

  Major Adverse Cardiovascular Events, Outpatient visit

  3 months

• Occurrence of major hemorrhagic events

  Outpatient visit

  1 month

• Occurrence of major hemorrhagic events

  Outpatient visit

  3 months

Study Arms (2)

Clopidogrel

Patients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows correct response to the effect of clopidogrel

Drug: Clopidogrel

Ticagrelor

Patients who undergo carotid stenting and dual antiplatelet therapy with ASA + clopidogrel and whose aggregometry test shows incorrect response to the effect of clopidogrel, therefore therapy is switched to ASA + ticagrelor

Drug: Ticagrelor

Interventions

Clopidogrel DRUG

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

Clopidogrel

Ticagrelor DRUG

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

Ticagrelor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

IRCCS Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Related Publications (6)

• Huibers A, Halliday A, Bulbulia R, Coppi G, de Borst GJ; ACST-2 Collaborative Group. Antiplatelet Therapy in Carotid Artery Stenting and Carotid Endarterectomy in the Asymptomatic Carotid Surgery Trial-2. Eur J Vasc Endovasc Surg. 2016 Mar;51(3):336-42. doi: 10.1016/j.ejvs.2015.11.002. Epub 2015 Dec 21.

  PMID: 26717867 BACKGROUND

• Ricotta JJ, Aburahma A, Ascher E, Eskandari M, Faries P, Lal BK; Society for Vascular Surgery. Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease. J Vasc Surg. 2011 Sep;54(3):e1-31. doi: 10.1016/j.jvs.2011.07.031.

  PMID: 21889701 BACKGROUND

• Bertrand ME, Rupprecht HJ, Urban P, Gershlick AH; CLASSICS Investigators. Double-blind study of the safety of clopidogrel with and without a loading dose in combination with aspirin compared with ticlopidine in combination with aspirin after coronary stenting : the clopidogrel aspirin stent international cooperative study (CLASSICS). Circulation. 2000 Aug 8;102(6):624-9. doi: 10.1161/01.cir.102.6.624.

  PMID: 10931801 BACKGROUND

• Hurst NL, Nooney VB, Raman B, Chirkov YY, De Caterina R, Horowitz JD. Clopidogrel "resistance": pre- vs post-receptor determinants. Vascul Pharmacol. 2013 Nov-Dec;59(5-6):152-61. doi: 10.1016/j.vph.2013.10.002. Epub 2013 Oct 16.

  PMID: 24140755 BACKGROUND

• Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.

  PMID: 19717846 BACKGROUND

• Park MW, Kim CJ, Kim MC, Choo EH, Hwang BH, Park CS, Kim HY, Yoo KD, Jeon DS, Jeong MH, Seung KB, Ahn Y, Chang K. A prospective, multicentre, randomised, open-label trial to compare the efficacy and safety of clopidogrel versus ticagrelor in stabilised patients with acute myocardial infarction after percutaneous coronary intervention: rationale and design of the TALOS-AMI trial. EuroIntervention. 2021 Feb 19;16(14):1170-1176. doi: 10.4244/EIJ-D-20-00187.

  PMID: 32718912 BACKGROUND

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Clopidogrel; Ticagrelor

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Adenosine; Purine Nucleosides; Purines; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: October 4, 2022
• Study Start: September 2, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Locations

IT (1)