Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients

Carotid Artery Diseases Clinical Trial

Official title:

Clinical Trial to Obtain the Highest Efficacy of Dual Antiplatelet Therapy After Carotid Artery Stenting in High Bleeding Risk Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06276374
• Other study ID #: SMC 2023-12-107
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Samsung Medical Center
• Contact: Woo-Keun Seo, Ph.D
• Phone: 82-2-3410-0799
• Email: mcastenosis[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To compare the safety of dual antiplatelet therapy with aspirin and clopidogrel and single antiplatelet therapy administered from 30 days to 12 months following carotid artery stenting on clinically significant bleeding and its prevention effects on net clinical events including combined cardiovascular and cerebrovascular accidents and major bleeding events in patients with carotid artery disease who are at high bleeding risk.

Description:

- Arm A : Single antiplatelet therapy (SAPT) group - 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) followed by 11 months of single antiplatelet therapy (100mg aspirin q.d. or 75mg clopidogrel q.d.) - Arm B : Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel - 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) followed by 11 months of dual antiplatelet therapy (100mg aspirin q.d. and 75mg clopidogrel q.d.)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1556
• Est. completion date: December 31, 2027
• Est. primary completion date: November 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Patients =19 years

2. Symptomatic patients with carotid artery stenosis* greater than 50% and asymptomatic patients with carotid artery stenosis* greater than 70% who are scheduled to undergo carotid artery stenting

3. High bleeding risk is defined as a Bleeding Academic Research Consortium type 3 or 5 bleeding risk of =4% at 1 year or a risk of an intracranial hemorrhage (ICH) of =1% at 1 year, Patients who meet at least one of the criteria for high bleeding risk** below

• The degree of stenosis is determined using the method performed in the North American Symptomatic Carotid Endarterectomy Trial.
• Criteria for high bleeding risk (= 1)
• Incidence of non-access site bleeding within 12 months prior to stenting (gastrointestinal tract or hematuria)
• Presence of BARC type 3 or 5 bleeding regardless of the onset time, but the cause has not been completely cured.
• Adults aged =75 years
• Thrombocytopenia < 100,000/mm3 (based on the screening test)
• Blood clotting disorders that increase bleeding (Von Willebrand disease, factor VII, VIII, IX, and XI deficiency)
• Patients with anemia defined as hemoglobin <12g/dL in men and <11g/dL in women or patients who donated blood within 4 weeks (based on the screening test)
• Patients received steroids or NSAIDs for =4 weeks
• Patients with active malignancy (except for nonmelanoma skin cancer)
• Renal disease (dialysis, transplantation, Estimated Glomerular Filtration Rate < 60ml/min per 1.73m2)
• Liver disease (cirrhosis with portal hypertension)
• Cerebral microbleeds = 5
• Stroke or transient ischemic attacks within 6 months
• Incidence of nontraumatic intracerebral hemorrhage regardless of duration or incidence of traumatic intracerebral hemorrhage within 12 months

Exclusion Criteria:

1. Incidence of net clinical events, including cardiovascular and cerebrovascular accidents or major bleeding events, within 30 days following carotid artery stenting

2. Coronary artery stenting or other vascular stenting or vascular recanalization within 1 year

3. Aspirin or clopidogrel hypersensitivity

4. Pregnant or breastfeeding women

5. Patients requiring anticoagulation for =12 months

6. Patients requiring administration of other antiplatelet therapies

7. Patients who are participating in another intervention clinical trial

Related Conditions & MeSH terms

• Carotid Artery Diseases

Intervention

Drug:
• Patients who are scheduled to undergo carotid artery stenting
Arm A : Single antiplatelet therapy (SAPT) with aspirin or clopidogrel - 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.)? Randomization ? 11 months of single antiplatelet therapy (100mg aspirin q.d. or 75mg clopidogrel q.d.) Arm B : Dual antiplatelet therapy (DAPT) with aspirin and clopidogrel - 1 month of dual antiplatelet therapy(100mg aspirin q.d. and 75mg clopidogrel q.d.) ? Randomization ? 11 months of dual antiplatelet therapy (100mg aspirin q.d. and 75mg clopidogrel q.d.)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Woo-Keun Seo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically significant bleeding	Bleeding Academic Research Consortium type 2, 3, or 5	From 30 days after carotid artery stenting until 12 months
Secondary	Combined cardiovascular and cerebrovascular accidents	Combined outcome of nonfatal stroke, nonfatal myocardial infarction, death due to cardio- and cerebrovascular diseases, and major bleeding events	From 30 days after carotid artery stenting until 12 months