Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis

Summary

This is a multicenter, open, randomized controlled trial to evaluate the efficacy and safety of carotid artery stenting/carotid endarterectomy versus best medical treatment for asymptomatic carotid artery stenosis in Chinese population.

Conditions

• Carotid Artery Stenting
• Carotid Endarterectomy
• Best Medical Treatment
• Carotid Artery Stenosis Asymptomatic

Interventions

PROCEDURE

Carotid Revascularization

Carotid Artery Stenting/Carotid Endarterectomy

DRUG

Medical Treatment

Aspirin 100mg/ day plus clopidogrel 75mg/ day for the first three months after enrollment or revascularization, aspirin 100mg/ day after three months, and the statin dose was adjusted according to blood lipids levels. Best medical treatment also includes risk factor control: good lifestyle, smoking cessation, weight control, regular exercise, SBP \< 140 mmHg, HDL \< 70 mg/dl (1.8mmol/L), and glycemic control. Patients with poor control of risk factors were dynamically adjusted during follow-up. In addition, patients undergoing CAS received dual antiplatelet therapy for at least 3 to 5 days before surgery, and patients undergoing CEA also received a preoperative oral antiplatelet drug (aspirin 100mg/ day, or clopidogrel 75mg/ day) for at least 3 days after enrollment.

Sponsors & Collaborators

• China-Japan Friendship Hospital

  collaborator OTHER

• First Affiliated Hospital Xi'an Jiaotong University

  collaborator OTHER

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Changhai Hospital

  collaborator OTHER

• Peking Union Medical College Hospital

  collaborator OTHER

• Hebei General Hospital

  collaborator OTHER

• The Second Hospital of Hebei Medical University

  collaborator OTHER

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  collaborator OTHER

• People's Hospital of Xinjiang Uygur Autonomous Region

  collaborator OTHER

• Fifth Affiliated Hospital of Zhengzhou University

  collaborator UNKNOWN

• Xuanwu Hospital, Beijing

  lead OTHER

Principal Investigators

• Yongquan Gu, Dr. · Xuanwu Hospital, Beijing

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-10-14

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• China

Study Locations