Stent-assisted Angioplasty of the Offending Intracranial Stenosis plus Optimal Medical Therapy versus Optimal Medical Therapy Alone "ASSIST II"

Completed

Phase N/A Results

Trial Description

To compare adjunctive stenting for the patients with symptomatic atherosclerotic intracranial stenosis with optimal medical therapy alone.

Interventions

  • Clopidogrel (Plavix┬«)Drug
    Other Names: Plavix
    Intervention Desc: Antiplatelet agent
  • Aspirin Drug
    Other Names: Aspirin at bedtime
    Intervention Desc: Antiplatelet agent; inhibits thromboxane A2; antipyretic
  • Probucol Drug
    Other Names: Probucol is produced by Otsuka Pharmaceutical
    Intervention Desc: Probucol is an anti-hyperlipidemic drug initially developed in the treatment of coronary artery disease.

Trial Design

Prospective, randomized, multi-center clinical trial.

Patient Involvement

Baseline angiography or MR angiography, CT and CT-perfusion and repeat at 6 months. NIHSS at 12 months. Participants will be randomized into the medical treatment group, or combined treatment group (medical therapy plus stent-assisted angioplasty) in the ratio of 1:2. All recruited patients will receive dual anti-platelets (aspirin and clopidogrel) and probucol. Modifiable risk factors will be controlled by life-style adjustment and/or pharmacological therapy according to major international guidelines. Participants in combined treatment group will additionally undergo stent- assisted angioplasty for the offending intracranial stenosis with Apollo stent. All patients will be scheduled clinical visits by the end of 1st, 3rd, 6th, 9th and 12th months.

Outcomes

Type Measure Time Frame Safety Issue
Primary Ipsilateral stroke, fatal or non-fatal, within 12 months; events of clinically-driven emergency revascularization related to the treated stenosis; mRS at 12 month.
Secondary Stroke and death unrelated to the target stenosis; acute myocardial infarction within 12 months; follow up cerebral angiography or MR angiography, CT and CT-perfusion at 6 month; NIHSS at 12 month.

Sponsors

Ministry of Health of the People's Republic of China, as a National Key Science and Technology Project (2004BA714B).