Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis
- Conditions
- Ischemic Stroke
- Interventions
- Device: intracranial angioplasty and stentingOther: intensive medical management
- Registration Number
- NCT00576693
- Lead Sponsor
- Medical University of South Carolina
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 451
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intensive medical management plus stenting intracranial angioplasty and stenting 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 management alone intensive medical management 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)
- Primary Outcome Measures
Name Time Method Any Stroke or Death Within 30 Days of Enrollment or Any Revascularization Procedure OR an Ischemic Stroke in the Territory of the Symptomatic Intracranial Artery Beyond 30 Days After Enrollment. Mean length of follow-up was 2.4 years Any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days after enrollment OR any stroke (ischemic, parenchymal brain hemorrhage, subarachnoid or intraventricular hemorrhage) or death within 30 days of any revascularization procedure of the qualifying symptomatic intracranial artery done during follow-up, OR an ischemic stroke in the territory of the symptomatic intracranial artery from day 31 after study entry to completion of follow-up.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (50)
Florida Hospital
🇺🇸Winter Park, Florida, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Mississippi
🇺🇸Jackson, Mississippi, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Glendale Adventist
🇺🇸Glendale, California, United States
UCLA
🇺🇸Los Angeles, California, United States
Cedars Sinai
🇺🇸Los Angeles, California, United States
Washington Hospital
🇺🇸Washington, District of Columbia, United States
University of Florida - Shands
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Central DuPage Hospital
🇺🇸Winfield, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Johns Hopkins
🇺🇸Baltimore, Maryland, United States
Providence St. John
🇺🇸Southfield, Michigan, United States
NYU Medical Center
🇺🇸New York, New York, United States
University of Buffalo
🇺🇸Buffalo, New York, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Cornell Medical College
🇺🇸New York, New York, United States
Stony Brook University Medical Center
🇺🇸Stony Brook, New York, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Moses Cone Medical Center
🇺🇸Greensboro, North Carolina, United States
University Hospitals Case Medical Center
🇺🇸Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Riverside Methodist
🇺🇸Columbus, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh
🇺🇸Pittsburgh, Pennsylvania, United States
Baylor University Medical Center
🇺🇸Dallas, Texas, United States
Erlanger Medical Center
🇺🇸Chattanooga, Tennessee, United States
Methodist Hospital
🇺🇸Houston, Texas, United States
UT Southwestern
🇺🇸Dallas, Texas, United States
Baylor St. Luke's
🇺🇸Houston, Texas, United States
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
MultiCare
🇺🇸Tacoma, Washington, United States
Sacred Heart Medical Center
🇺🇸Spokane, Washington, United States
Sentera
🇺🇸Norfolk, Virginia, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Henry Ford Medical Center
🇺🇸Detroit, Michigan, United States
UCSF
🇺🇸San Francisco, California, United States
Mayo
🇺🇸Phoenix, Arizona, United States
Barrow Neurological Institute - St. Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
Wayne State
🇺🇸Detroit, Michigan, United States
Scott & White - Texas A&M
🇺🇸Temple, Texas, United States
University of Miami
🇺🇸Miami, Florida, United States
UAB Medical Center
🇺🇸Birmingham, Alabama, United States
Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States