Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)
Tracking Information | |||||
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First Received Date ICMJE | December 7, 2007 | ||||
Last Updated Date | August 4, 2011 | ||||
Start Date ICMJE | October 2008 | ||||
Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
To determine whether intracranial stenting (Wingspan stent) with intensive medical therapy is superior to the medical therapy alone for preventing second stroke in high-risk patients with symptomatic stenosis of a major intracranial artery. [ Time Frame: mean of 2 years ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00576693 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis | ||||
Official Title ICMJE | Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis | ||||
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 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. |
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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 60 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. There are two follow-up phases to this study: Phase 1 includes all patients enrolled in the study and is complete after all active patients (i.e., those that have not already reached a primary endpoint, died, or withdrawn consent to participate in the trial) have been followed for at least 1 year after enrollment. The mean length of follow-up in Phase I is expected to be two years. The purpose of Phase 1 follow-up is to compare intensive medical therapy plus angioplasty and stenting with intensive medical therapy alone to determine which therapy is more effective at preventing the primary endpoint. Phase 2 begins at the conclusion of Phase 1 and includes only active patients in the stenting arm who have not yet completed three years of follow-up. When all active patients in the stenting arm have completed 3 years of follow-up, they will have completed their participation in the study. The purpose of Phase 2 is to determine the outcome of stented patients over a longer follow-up period. We anticipate Phase 1 will be completed in year 5 of the trial and Phase 2 will be completed 2 years later. All patients randomized to the medical arm who do not have a primary endpoint or die during the trial will be followed for a minimum of 1 year and a maximum of 3 years, whereas all patients randomized to the stenting arm who do not have a primary endpoint or die during the trial will be followed for 3 years. Once a patient in either arm has a primary endpoint, their study participation is considered complete and no more follow-up is required except for a follow-up visit at 90 days after a non-fatal primary endpoint to assess disability. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Ischemic Stroke | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | Chimowitz MI, Lynn MJ, Derdeyn CP, Turan TN, Fiorella D, Lane BF, Janis LS, Lutsep HL, Barnwell SL, Waters MF, Hoh BL, Hourihane JM, Levy EI, Alexandrov AV, Harrigan MR, Chiu D, Klucznik RP, Clark JM, McDougall CG, Johnson MD, Pride GL Jr, Torbey MT, Zaidat OO, Rumboldt Z, Cloft HJ; SAMMPRIS Trial Investigators. Stenting versus aggressive medical therapy for intracranial arterial stenosis. N Engl J Med. 2011 Sep 15;365(11):993-1003. Epub 2011 Sep 7. | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Active, not recruiting | ||||
Estimated Enrollment ICMJE | 764 | ||||
Estimated Completion Date | October 2013 | ||||
Estimated Primary Completion Date | October 2013 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | INCLUSION CRITERIA
EXCLUSION CRITERIA
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Gender | Both | ||||
Ages | 30 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00576693 | ||||
Other Study ID Numbers ICMJE | R01NS058728-01A1, NINDS, CRC, 1U01NS058728-01A1 | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | Marc Chimowitz, MBChB, Medical University of South Carolina | ||||
Study Sponsor ICMJE | Medical University of South Carolina | ||||
Collaborators ICMJE |
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Investigators ICMJE |
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Information Provided By | Medical University of South Carolina | ||||
Verification Date | March 2010 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |