We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576693
First Posted: December 19, 2007
Last Update Posted: July 11, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Results First Submitted: May 6, 2014  
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

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Intensive Medical Management Plus Stenting

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 Management Alone

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)


Participant Flow:   Overall Study
    Intensive Medical Management Plus Stenting   Intensive Medical Management Alone
STARTED   224   227 
COMPLETED   214   203 
NOT COMPLETED   10   24 
Lost to Follow-up                7                11 
Withdrawal by Subject                3                13 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Intensive Medical Management Plus Stenting

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 Management Alone

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 Total of all reporting groups

Baseline Measures
   Intensive Medical Management Plus Stenting   Intensive Medical Management Alone   Total 
Overall Participants Analyzed 
[Units: Participants]
 224   227   451 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.0  (10.7)   59.5  (11.8)   60.2  (11.3) 
Gender 
[Units: Participants]
     
Female   97   82   179 
Male   127   145   272 
Race/Ethnicity, Customized 
[Units: Participants]
     
Black   55   49   104 
White   160   162   322 
Other   9   16   25 
History of Hypertension 
[Units: Participants]
     
Yes   200   203   403 
No   24   24   48 
History of Lipid Disorder 
[Units: Participants]
     
Yes   195   202   397 
No   29   25   54 
Smoking [1] 
[Units: Participants]
     
Never   90   78   168 
Previously   79   80   159 
Currently   54   69   123 
[1]

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] 
[Units: Participants]
     
Yes   105   103   208 
No   119   124   243 
[1] 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 
[Units: mmHg]
Mean (Standard Deviation)
 143.9  (20.6)   146.8  (21.8)   145.4  (21.3) 
Low Density Lipoprotein Cholesterol 
[Units: Mg/dl]
Mean (Standard Deviation)
 96.2  (38.4)   97.7  (36.6)   97.0  (37.5) 
Body Mass Index 
[Units: Kg/m^2]
Mean (Standard Deviation)
 30.3  (6.2)   30.7  (6.3)   30.5  (6.3) 
History of Coronary Artery Disease 
[Units: Participants]
     
Yes   47   59   106 
No   177   168   345 
History of Stroke (Not Qualifying Event) 
[Units: Participants]
     
Yes   60   58   118 
No   164   169   333 
Qualifying Event 
[Units: Participants]
     
Stroke   142   152   294 
TIA   82   75   157 
On Antithrombotic Therapy at Qualifying Event 
[Units: Participants]
     
Yes   144   140   284 
No   80   87   167 
Time from Qualifying Event to Randomization 
[Units: Days]
Median (Inter-Quartile Range)
 7 
 (4 to 16) 
 7 
 (4 to 19) 
 7 
 (4 to 17.5) 
Symptomatic Qualifying Artery 
[Units: 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] 
[Units: % of the diameter the artery]
Mean (Standard Deviation)
 80  (7)   81  (7)   81  (7) 
[1] According to a reading of the cerebral angiogram by the site interventionist.


  Outcome Measures

1.  Primary:   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.   [ Time Frame: Mean length of follow-up was 2.4 years ]


  Serious Adverse Events
  Hide Serious Adverse Events

Time Frame Mean length of follow-up was 2.4 years
Additional 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.

Reporting Groups
  Description
Intensive Medical Management Plus Stenting

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 Management Alone

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)


Serious Adverse Events
    Intensive Medical Management Plus Stenting   Intensive Medical Management Alone
Total, Serious Adverse Events     
# participants affected / at risk   146/224 (65.18%)   121/227 (53.30%) 
Blood and lymphatic system disorders     
Blood / Bone Marrow † 2     
# participants affected / at risk   4/224 (1.79%)   3/227 (1.32%) 
Coagulation † 2     
# participants affected / at risk   0/224 (0.00%)   1/227 (0.44%) 
Lymphatics † 2     
# participants affected / at risk   1/224 (0.45%)   0/227 (0.00%) 
Hemorrhage / Bleeding † 2     
# participants affected / at risk   1/224 (0.45%)   0/227 (0.00%) 
Cardiac disorders     
Myocardial Infarction † 1     
# participants affected / at risk   5/224 (2.23%)   9/227 (3.96%) 
Cardiac Arrhythmia † 2     
# participants affected / at risk   13/224 (5.80%)   7/227 (3.08%) 
Cardiac General † 2     
# participants affected / at risk   14/224 (6.25%)   18/227 (7.93%) 
Ear and labyrinth disorders     
Auditory / Ear † 2     
# participants affected / at risk   1/224 (0.45%)   1/227 (0.44%) 
Endocrine disorders     
Endocrine † 2     
# participants affected / at risk   3/224 (1.34%)   2/227 (0.88%) 
Eye disorders     
Ocular / Visual † 2     
# participants affected / at risk   3/224 (1.34%)   5/227 (2.20%) 
Gastrointestinal disorders     
Gastrointestinal † 2     
# participants affected / at risk   13/224 (5.80%)   12/227 (5.29%) 
General disorders     
Systemic Hemorrhage † 1     
# participants affected / at risk   15/224 (6.70%)   8/227 (3.52%) 
Constitutional Symptoms † 2     
# participants affected / at risk   2/224 (0.89%)   2/227 (0.88%) 
Pain † 2     
# participants affected / at risk   9/224 (4.02%)   9/227 (3.96%) 
Death † 1     
# participants affected / at risk   13/224 (5.80%)   13/227 (5.73%) 
Hepatobiliary disorders     
Hepatobiliary / Pancreas † 2     
# participants affected / at risk   3/224 (1.34%)   3/227 (1.32%) 
Immune system disorders     
Allergy / Immunology † 2     
# participants affected / at risk   3/224 (1.34%)   0/227 (0.00%) 
Infections and infestations     
Infection † 2     
# participants affected / at risk   10/224 (4.46%)   5/227 (2.20%) 
Metabolism and nutrition disorders     
Metabolic / Laaboratory † 2     
# participants affected / at risk   10/224 (4.46%)   14/227 (6.17%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal / Soft Tissue † 2     
# participants affected / at risk   8/224 (3.57%)   6/227 (2.64%) 
Nervous system disorders     
Ischemic Stroke in the Territory of Qualifying Symptomatic Artery † 1     
# participants affected / at risk   40/224 (17.86%)   30/227 (13.22%) 
Ischemic Stroke Not in the Territory of the Qualifying Symptomatic Artery † 1     
# participants affected / at risk   5/224 (2.23%)   10/227 (4.41%) 
Symptomatic Intracranial Hemorrhage † 1     
# participants affected / at risk   12/224 (5.36%)   1/227 (0.44%) 
Intracranial Hematoma † 1     
# participants affected / at risk   0/224 (0.00%)   1/227 (0.44%) 
Transient Ischemic Attack / Cerebral Infarct with Temporary Signs † 1     
# participants affected / at risk   30/224 (13.39%)   29/227 (12.78%) 
Neurology † 2     
# participants affected / at risk   26/224 (11.61%)   19/227 (8.37%) 
Asymptomatic Intracranial Hemorrhage † 1     
# participants affected / at risk   1/224 (0.45%)   0/227 (0.00%) 
Renal and urinary disorders     
Renal / Genitourinary † 2     
# participants affected / at risk   10/224 (4.46%)   5/227 (2.20%) 
Reproductive system and breast disorders     
Sexual / Reproductive † 2     
# participants affected / at risk   2/224 (0.89%)   1/227 (0.44%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary / Upper Respiratory † 2     
# participants affected / at risk   7/224 (3.13%)   6/227 (2.64%) 
Skin and subcutaneous tissue disorders     
Dermatology / Skin † 2     
# participants affected / at risk   3/224 (1.34%)   1/227 (0.44%) 
Surgical and medical procedures     
Surgery / Intraoperative Injury † 2     
# participants affected / at risk   4/224 (1.79%)   3/227 (1.32%) 
Vascular disorders     
Vascular † 2     
# participants affected / at risk   10/224 (4.46%)   6/227 (2.64%) 
Pulmonary Embolus † 1     
# participants affected / at risk   0/224 (0.00%)   2/227 (0.88%) 
Cerebral Venous Thrombosis † 1     
# participants affected / at risk   1/224 (0.45%)   1/227 (0.44%) 
Deep Vein Thrombosis † 1     
# participants affected / at risk   2/224 (0.89%)   2/227 (0.88%) 
Complications of Acute Ischemia of a Limb or Internal Organ † 1     
# participants affected / at risk   4/224 (1.79%)   2/227 (0.88%) 
Events were collected by systematic assessment
1 Term from vocabulary, Study Protocol
2 Term from vocabulary, CTCAE (3.0)




  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

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
e-mail: mchimow@musc.edu


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: July 11, 2014