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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

1140 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-02

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Platelet Inhibition and Transcranial Doppler (TCD)-Detected Microemboli During and After Carotid Artery Stenting (CAS) in Asymptomatic Patients Prior to Cardiac Surgery

NCT01146301

Carotid Stenosis

COMPLETED PHASE4

Residual Platelet Reactivity in Patients on Antiplatelet Therapy After Carotid Angioplasty With Stenting

NCT01449617

Carotid Artery Disease

UNKNOWN

Ticagrelor Versus Clopidogrel in Carotid Artery Stenting

NCT02677545

Carotid Artery Stenosis

COMPLETED PHASE2

Safety and Effectiveness of Ticagrelor in Patients Undergoing Carotid Stenting

NCT04091074

Carotid Stenosis

UNKNOWN PHASE1

Ticagrelor And PrEconditioning in Patients With coronaRy Artery diSease

NCT02701140

Myocardial Ischemia

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients' records will be reviewed for clinical data (age, sex, height and weight), the presence of cardiovascular risk factors (diabetes mellitus, hypertension, dyslipidemia, smoking habits, coronary artery disease, chronic obstructive pulmonary disease), features of the carotid plaque (type of plaque and degree of carotid stenosis, according to ECST measurement), and status of the contralateral carotid artery. The occurrence of preoperative neurologic symptoms within the previous 6 months will also be recorded, as evaluated by the neurologist.

Preoperative and postoperative drug intake will be investigated, with particular attention to statins, beta blockers, angiotensin-converting enzyme (ACE) inhibitors, antiplatelet therapy and anticoagulant therapy.

Laboratory data such as serum creatinine, platelet counts, Red blood cell Distribution Width (RDW), Prothrombin Time (PT), International Normalized Ratio (INR), activated Partial Thromboplastin Time (aPTT) and ratio will be also assessed.

After operation, patients will be followed up three times in the first year (at 1 month, 6 months, and 12 months) and annually thereafter, using ultrasound. An angio-Computed Tomography scan will be required when complications were detected at ultrasound examination. During follow-up, data will be collected about the occurrence of death, stent thrombosis, cerebrovascular events, cardiac events, major haemorrhagic events.

Determination of the effectiveness of antiplatelet drugs The effectiveness of antiplatelet drugs will be evaluated through the impedance aggregometry test, conducted with the Multiplate® platelet function analysis V2.03.11 (Roche, Basel, Switzerland).

Multiplate® technology is based on the principle of electrical impedance aggregometry for the determination of platelet function on whole blood.

The instrument has five independent channels for parallel measurement and is connected to a computer equipped with specific software for the analysis and display of results in real time.

The blood and reagents are placed in a disposable cuvette containing two pairs of electrodes, representing two independent sensor units for a duplicate measurement. The platelets activated by the specific agonist adhere to the metal surface of the sensors, forming an insulating layer and increasing the electrical impedance between the electrodes. The change in impedance due to adhesion and platelet aggregation is represented as a function of time. The area included within the aggregation curve, used to measure aggregation, is expressed in arbitrary aggregation units (U). Since the change in impedance is measured simultaneously on two sensors, the results of each test are expressed as the average value of the two aggregation curves obtained.

Blood sampling to assess platelet aggregation was performed at the patient's hospitalization (in the event that he was already taking clopidogrel), or at least 6 hours after the start of antiplatelet therapy with clopidogrel.

The aggregometry test evaluates the efficacy of salicylates (ASPI-test, aggregation with the use of arachidonic acid: normal reference values 71-115 U) and the efficacy of drugs that act on the adenosine diphosphate (ADP) receptor such as thienopyridines. (ADP-test, ADP-triggered aggregation: normal reference values 57-113 U), compared to the positive control for platelet reactivity by the thrombin-receptor activating peptide (TRAP)-6 (TRAP-test: normal reference values 84-128 U).

In particular, 4 mL of either arterial or venous whole blood will be collected in a tube containing the specific anticoagulant hirudin. Three hundred µL of whole blood diluted with 300 µL of physiological solution will be placed in a disposable cuvette with the aid of an automatic pipette, and left to incubate at 37 ºC for 3 minutes. After incubation, a specific agonist will be added for the required exam. The platelet aggregation value will be measured over the next 6 minutes.

The effectiveness of clopidogrel is defined by the evidence of ADP-test which results to be under normal reference values, otherwise the patient is considered to be resistant to the effect of the drug.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clopidogrel, Poor Metabolism of Carotid Stenosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Clopidogrel

Intervention Type DRUG

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

Ticagrelor

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clopidogrel

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

Intervention Type DRUG

Ticagrelor

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

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No