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Stenting vs. Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Stenosis (SAMMPRIS)

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ClinicalTrials.gov Identifier: NCT00576693
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : July 11, 2014
Last Update Posted : May 30, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Marc Chimowitz, Medical University of South Carolina

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Ischemic Stroke
Interventions Device: intracranial angioplasty and stenting
Other: intensive medical management
Enrollment 451

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Intensive Medical Management Plus Stenting Intensive Medical Management Alone
Hide Arm/Group Description

intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent 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).

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 cardia

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)

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)

Period Title: Overall Study
Started 224 227
Completed 214 203
Not Completed 10 24
Reason Not Completed
Lost to Follow-up             7             11
Withdrawal by Subject             3             13
Arm/Group Title Intensive Medical Management Plus Stenting Intensive Medical Management Alone Total
Hide Arm/Group Description

intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent 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).

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 cardia

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)

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)

Total of all reporting groups
Overall Number of Baseline Participants 224 227 451
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 224 participants 227 participants 451 participants
61.0  (10.7) 59.5  (11.8) 60.2  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Female
97
  43.3%
82
  36.1%
179
  39.7%
Male
127
  56.7%
145
  63.9%
272
  60.3%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Black 55 49 104
White 160 162 322
Other 9 16 25
History of Hypertension  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Yes 200 203 403
No 24 24 48
History of Lipid Disorder  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Yes 195 202 397
No 29 25 54
Smoking   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Never 90 78 168
Previously 79 80 159
Currently 54 69 123
[1]
Measure Description:

Based on the Physician-based Assessment and Counseling for Exercise (PACE) Smoking Score.

The data value for smoking status was missing for 1 patient in the intensive medical management plus stenting group.

Diabetes   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Yes 105 103 208
No 119 124 243
[1]
Measure Description: A patient is considered diabetic at baseline if there is a history of diabetes or if the baseline hemoglobin A1c > 6.5%.
Systolic Blood Pressure  
Mean (Standard Deviation)
Unit of measure:  mmHg
Number Analyzed 224 participants 227 participants 451 participants
143.9  (20.6) 146.8  (21.8) 145.4  (21.3)
Low Density Lipoprotein Cholesterol  
Mean (Standard Deviation)
Unit of measure:  Mg/dl
Number Analyzed 224 participants 227 participants 451 participants
96.2  (38.4) 97.7  (36.6) 97.0  (37.5)
Body Mass Index  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 224 participants 227 participants 451 participants
30.3  (6.2) 30.7  (6.3) 30.5  (6.3)
History of Coronary Artery Disease  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Yes 47 59 106
No 177 168 345
History of Stroke (Not Qualifying Event)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Yes 60 58 118
No 164 169 333
Qualifying Event  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Stroke 142 152 294
TIA 82 75 157
On Antithrombotic Therapy at Qualifying Event  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Yes 144 140 284
No 80 87 167
Time from Qualifying Event to Randomization  
Median (Inter-Quartile Range)
Unit of measure:  Days
Number Analyzed 224 participants 227 participants 451 participants
7
(4 to 16)
7
(4 to 19)
7
(4 to 17.5)
Symptomatic Qualifying Artery  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 224 participants 227 participants 451 participants
Internal Carotid Artery 45 49 94
Middle Cerebral Artery 92 105 197
Vertebral Artery 38 22 60
Basilar Artery 49 51 100
Percent Stenosis of Symptomatic Qualifying Artery   [1] 
Mean (Standard Deviation)
Unit of measure:  % of the diameter the artery
Number Analyzed 224 participants 227 participants 451 participants
80  (7) 81  (7) 81  (7)
[1]
Measure Description: According to a reading of the cerebral angiogram by the site interventionist.
1.Primary Outcome
Title 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.
Hide Description 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.
Time Frame Mean length of follow-up was 2.4 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study were included in the primary outcome analysis.
Arm/Group Title Intensive Medical Management Plus Stenting Intensive Medical Management Alone
Hide Arm/Group Description:

intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent 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).

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 cardia

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)

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)

Overall Number of Participants Analyzed 224 227
Measure Type: Number
Unit of Measure: participants
52 34
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intensive Medical Management Plus Stenting, Intensive Medical Management Alone
Comments The statistical analysis was based on a comparison of the of the two treatment groups with respect to the time to a primary outcome using the logrank test.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0252
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Time Frame Mean length of follow-up was 2.4 years
Adverse Event Reporting Description The prespecified study outcomes were explicitly requested on the adverse event form. Any other adverse event was to be reported if it was either serious or related to a study intervention according to prespecified criteria and classified on the adverse event form using the Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0.
 
Arm/Group Title Intensive Medical Management Plus Stenting Intensive Medical Management Alone
Hide Arm/Group Description

intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent 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).

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 cardia

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)

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)

All-Cause Mortality
Intensive Medical Management Plus Stenting Intensive Medical Management Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intensive Medical Management Plus Stenting Intensive Medical Management Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   146/224 (65.18%)   121/227 (53.30%) 
Blood and lymphatic system disorders     
Blood / Bone Marrow  2  4/224 (1.79%)  3/227 (1.32%) 
Coagulation  2  0/224 (0.00%)  1/227 (0.44%) 
Lymphatics  2  1/224 (0.45%)  0/227 (0.00%) 
Hemorrhage / Bleeding  2  1/224 (0.45%)  0/227 (0.00%) 
Cardiac disorders     
Myocardial Infarction  1  5/224 (2.23%)  9/227 (3.96%) 
Cardiac Arrhythmia  2  13/224 (5.80%)  7/227 (3.08%) 
Cardiac General  2  14/224 (6.25%)  18/227 (7.93%) 
Ear and labyrinth disorders     
Auditory / Ear  2  1/224 (0.45%)  1/227 (0.44%) 
Endocrine disorders     
Endocrine  2  3/224 (1.34%)  2/227 (0.88%) 
Eye disorders     
Ocular / Visual  2  3/224 (1.34%)  5/227 (2.20%) 
Gastrointestinal disorders     
Gastrointestinal  2  13/224 (5.80%)  12/227 (5.29%) 
General disorders     
Systemic Hemorrhage  1  15/224 (6.70%)  8/227 (3.52%) 
Constitutional Symptoms  2  2/224 (0.89%)  2/227 (0.88%) 
Pain  2  9/224 (4.02%)  9/227 (3.96%) 
Death  1  13/224 (5.80%)  13/227 (5.73%) 
Hepatobiliary disorders     
Hepatobiliary / Pancreas  2  3/224 (1.34%)  3/227 (1.32%) 
Immune system disorders     
Allergy / Immunology  2  3/224 (1.34%)  0/227 (0.00%) 
Infections and infestations     
Infection  2  10/224 (4.46%)  5/227 (2.20%) 
Metabolism and nutrition disorders     
Metabolic / Laaboratory  2  10/224 (4.46%)  14/227 (6.17%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal / Soft Tissue  2  8/224 (3.57%)  6/227 (2.64%) 
Nervous system disorders     
Ischemic Stroke in the Territory of Qualifying Symptomatic Artery  1  40/224 (17.86%)  30/227 (13.22%) 
Ischemic Stroke Not in the Territory of the Qualifying Symptomatic Artery  1  5/224 (2.23%)  10/227 (4.41%) 
Symptomatic Intracranial Hemorrhage  1  12/224 (5.36%)  1/227 (0.44%) 
Intracranial Hematoma  1  0/224 (0.00%)  1/227 (0.44%) 
Transient Ischemic Attack / Cerebral Infarct with Temporary Signs  1  30/224 (13.39%)  29/227 (12.78%) 
Neurology  2  26/224 (11.61%)  19/227 (8.37%) 
Asymptomatic Intracranial Hemorrhage  1  1/224 (0.45%)  0/227 (0.00%) 
Renal and urinary disorders     
Renal / Genitourinary  2  10/224 (4.46%)  5/227 (2.20%) 
Reproductive system and breast disorders     
Sexual / Reproductive  2  2/224 (0.89%)  1/227 (0.44%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary / Upper Respiratory  2  7/224 (3.13%)  6/227 (2.64%) 
Skin and subcutaneous tissue disorders     
Dermatology / Skin  2  3/224 (1.34%)  1/227 (0.44%) 
Surgical and medical procedures     
Surgery / Intraoperative Injury  2  4/224 (1.79%)  3/227 (1.32%) 
Vascular disorders     
Vascular  2  10/224 (4.46%)  6/227 (2.64%) 
Pulmonary Embolus  1  0/224 (0.00%)  2/227 (0.88%) 
Cerebral Venous Thrombosis  1  1/224 (0.45%)  1/227 (0.44%) 
Deep Vein Thrombosis  1  2/224 (0.89%)  2/227 (0.88%) 
Complications of Acute Ischemia of a Limb or Internal Organ  1  4/224 (1.79%)  2/227 (0.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Study Protocol
2
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Intensive Medical Management Plus Stenting Intensive Medical Management Alone
Affected / at Risk (%) Affected / at Risk (%)
Total   117/224 (52.23%)   118/227 (51.98%) 
Cardiac disorders     
Cardiac General  2  39/224 (17.41%)  35/227 (15.42%) 
Gastrointestinal disorders     
Gastrointestinal  2  5/224 (2.23%)  15/227 (6.61%) 
General disorders     
Systemic Hemorrhage  1  29/224 (12.95%)  24/227 (10.57%) 
Pain  2  14/224 (6.25%)  11/227 (4.85%) 
Metabolism and nutrition disorders     
Metabolic / Laboratory  2  17/224 (7.59%)  13/227 (5.73%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal / Soft Tissue  2  21/224 (9.38%)  9/227 (3.96%) 
Nervous system disorders     
Transient Ischemic Attack / Cerebral Infarct with Temporary Signs  1  27/224 (12.05%)  34/227 (14.98%) 
Neurology  2  25/224 (11.16%)  25/227 (11.01%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary / Upper Respiratory  2  12/224 (5.36%)  10/227 (4.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, Study Protocol
2
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Marc I. Chimowitz, MBChB
Organization: Medical University of South Carolina
Phone: 843-792-3020
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marc Chimowitz, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00576693     History of Changes
Other Study ID Numbers: R01NS058728-01A1
NINDS ( Other Identifier: NINDS )
CRC ( Other Identifier: NINDS )
1U01NS058728-01A1 ( U.S. NIH Grant/Contract )
First Submitted: December 7, 2007
First Posted: December 19, 2007
Results First Submitted: May 6, 2014
Results First Posted: July 11, 2014
Last Update Posted: May 30, 2018