Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      PRIMARY HYPOTHESIS:

      Compared with intensive medical therapy alone, intracranial angioplasty and stenting combined
      with intensive medical therapy will decrease the risk of the primary endpoint by 35% over a
      mean follow-up of two years in high-risk patients patients with 70% - 99% intracranial
      stenosis who had a transient ischemic attack (TIA) or stroke within 30 days prior to
      enrollment) with symptomatic stenosis of a major intracranial artery.

      SUMMARY:

      The best treatment for prevention of another stroke or TIA in patients with narrowing of one
      of the arteries in the brain is uncertain. A common treatment is the use of anti-clotting
      medications to prevent blood clots from forming in the narrowed vessel. There are a variety
      of medicines used for this purpose. These medications are usually taken for the rest of a
      patient's life.

      However, a treatment that has been used successfully together with anti-clotting medications
      in patients with narrowing of the blood vessels of the heart is now being studied in the
      blood vessels of the brain. This treatment is called stenting.

      Recent research has also indicated a benefit in prevention of recurring stroke by Intensive
      Medical Therapy, which is defined as treating risk factors for stroke like high blood
      pressure, elevated LDL (low density lipids - the "bad" form of cholesterol) and diabetes. The
      purpose of this study is to compare the safety and effectiveness of either Intensive Medical
      Therapy PLUS Stenting or Intensive Medical Therapy ONLY in preventing stroke, heart attacks
      or death.

      The study will enroll patients over a 5 year period. Each participant will be involved in the
      study for a minimum of 1 year and a maximum of 3 years.

      Fifty different medical centers in the United States are part of this study. Both the
      Clinical Coordinating Center and the Statistical Coordinating Center for the entire study
      will be located at Emory University.
    

Detailed description: 
      This will be an investigator initiated and designed Phase III multicenter trial in which
      patients with TIA or non-disabling stroke within 30 days prior to enrollment that is caused
      by 70% - 99% stenosis of a major intracranial artery (MCA, carotid, vertebral, or basilar)
      will be randomized (1:1) at approximately 50 sites to:

      intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg
      per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel
      beyond 90 days for a cardiac indication, and aggressive risk factor management primarily
      targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)

      OR

      intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding
      nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery
      systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up,
      clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends
      continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor
      management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and
      LDL < 70 mg / dl).

      Risk factor management will be performed by the study neurologist at each site who will be
      assisted by an innovative, evidence-based, educational, lifestyle modification program
      (INTERxVENT) that will be administered at regularly scheduled times to all patients
      throughout the study.

      All patients enrolled in the trial will be followed until the first of the following: 90 days
      after a primary endpoint, death, or the close-out visit in the trial, which will occur within
      a window from 60 days before March 31, 2012 to 30 days after March 31, 2013. Patients who do
      not die or have a primary endpoint during follow-up will be followed for 2-4.5 years.
    

Intervention name(s): intracranial angioplasty and stenting; intensive medical management
Intervention type(s): Device; Other
Intervention description(s): intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).; intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)
Other intervention name(s): Wingspan stent; Gateway balloon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ischemic stroke; intracranial stenting; vascular risk factor management