Trials / Unknown
UnknownNCT05623904
Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis
Carotid Revascularization Versus Best Medical Treatment for Asymptomatic Carotid Stenosis: a Multicenter, Open, Randomized Controlled Trial in Chinese Population
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 1,056 (estimated)
- Sponsor
- Xuanwu Hospital, Beijing · Academic / Other
- Sex
- All
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. The study will be conducted at 11 centers and is expected to enroll 1056 patients.
Conditions
- Carotid Artery Stenting
- Carotid Endarterectomy
- Best Medical Treatment
- Carotid Artery Stenosis Asymptomatic
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-10-14
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2022-11-21
- Last updated
- 2023-01-31
Locations
11 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05623904. Inclusion in this directory is not an endorsement.