Antiplatelet Therapy in Carotid Artery Stenting and Carotid Endarterectomy in the Asymptomatic Carotid Surgery Trial-2.
A Huibers, A Halliday, R Bulbulia...
https://pubmed.ncbi.nlm.nih.gov/26717867Actively Recruiting
Age: 18Years +
All Genders
ID05566301
MULTIcentric Study About RESistance to CLOpidogrel in Dual Antiplatelet Therapy for Carotid Stenting
Led by IRCCS Policlinico S. Donato · Updated on 2025-05-06
1140
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate if there is a significant difference in outcomes between patients who do not respond well to Clopidogrel and are switched to Ticagrelor, compared to those who respond well to Clopidogrel, both groups undergoing carotid stenting. The study focuses on the occurrence of death, major cardiovascular events, and major bleeding at one and three months after the procedure. It also seeks to identify clinical and pharmacological factors that may cause resistance to Clopidogrel. Patients will be treated with carotid stenting and dual antiplatelet therapy including aspirin plus Clopidogrel. Those whose platelet function tests show resistance to Clopidogrel will be switched to aspirin plus Ticagrelor. The effectiveness of antiplatelet drugs is assessed using a blood test measuring platelet aggregation. Blood samples are collected either at hospital admission or after six hours of starting Clopidogrel, and tests are performed to evaluate drug response. Participants' clinical data, cardiovascular risk factors, carotid plaque features, and medication use are recorded. After surgery, patients have follow-up visits at 1, 6, and 12 months during the first year, and then yearly, including ultrasound exams and additional scans if needed. Researchers track outcomes including death, stent thrombosis, stroke, heart events, and bleeding. This study is observational and collects data over time to understand treatment responses and complications.
CONDITIONS
Brief Title
Multicentric Study on Clopidogrel Resistance in DAPT for CAS (MULTI-RESCLOSA)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adult patients (age > 18 years)
- Patients who have given their consent to participate in the study
- Patients treated for carotid stenosis by stenting at participating vascular surgery centers
You will not qualify if you...
- Patients under 18 years old
- Patients who have not given their consent to participate
- Patients with carotid stenosis not suitable for stenting
- Pregnant or lactating women
- Any condition where carotid stenting is contraindicated regardless of the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Duration of standard dual antiplatelet therapy following carotid stenting
Participants undergo carotid stenting and receive dual antiplatelet therapy with ASA plus clopidogrel or ticagrelor depending on their response to clopidogrel as assessed by the aggregometry test.
Blood sampling at hospitalization or at least 6 hours after starting clopidogrel
Post-operative Follow-up
Duration - 1 year with possible annual follow-up thereafter
Participants are followed up with ultrasound examinations and clinical assessments to monitor for complications, stent thrombosis, cerebrovascular events, cardiac events, major hemorrhagic events, and death.
3 visits in the first year at 1 month, 6 months, and 12 months, and annual visits thereafter
Trial Site Locations
Total: 1 location
1
IRCCS Policlinico San Donato
San Donato Milanese, Milan, Italy, 20097
Actively Recruiting
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Updated Society for Vascular Surgery guidelines for management of extracranial carotid disease.
John J Ricotta, Ali Aburahma, Enrico Ascher...
https://pubmed.ncbi.nlm.nih.gov/21889701Double-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).
M E Bertrand, H J Rupprecht, P Urban...
https://pubmed.ncbi.nlm.nih.gov/10931801Clopidogrel "resistance": pre- vs post-receptor determinants.
N L Hurst, V B Nooney, B Raman...
https://pubmed.ncbi.nlm.nih.gov/24140755Ticagrelor versus clopidogrel in patients with acute coronary syndromes.
Lars Wallentin, Richard C Becker, Andrzej Budaj...
https://pubmed.ncbi.nlm.nih.gov/19717846A 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.
Mahn-Won Park, Chan Joon Kim, Min-Chul Kim...
https://pubmed.ncbi.nlm.nih.gov/32718912