drugset / Trial / NCT02689037

Angioplasty and Stenting for Patients With Symptomatic Intracranial Atherosclerosis

NCT02689037

Phase 3 Unknown 394 enrolled The 476th Hospital of People's Liberation Army
RandomizedParallel-groupSingle-blindTreatment

Summary

Background: Effectiveness of Percutaneous transluminal angioplasty and stenting (PTAS) on prevention of events of stroke and death in patients with symptomatic intracranial atherosclerosis (ICAS) is controversial. Aim: to determine whether PTAS plus medical treatment (MT) are superior to MT alone in preventing events of stroke and death in patients with symptomatic ICAS. Methods: The investigators will carry out a randomized controlled trial in 3 hospitals in China. A total of 198 patients with ICAS will be randomized into 2 groups: PTAS+MT and MT group. All patients will receive aspirin (100 mg daily) and clopidogrel (75 mg daily) immediately after randomization, and patients in PTAS+MT group will receive surgery within 5 days after randomization. The patients will be followed up for 1 year after randomization and assessed for events of stroke and death at 30 days and 1 year after randomization, the incidence of recurrent ischaemic stroke in the stenting-involved vascular territory at 30 days and 1 year after randomization, incidence of in-stent restenosis at 1 year after randomization,etc.

Timeline

Start
2016-04
Primary completion
2018-12
Completion
2019-12

Drugs

EvaluationDrugModalityDoseRoute
Background Aspirin Small molecule 100 mg
Background Clopidogrel Small molecule 75 mg