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

This study has been completed.
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
ClinicalTrials.gov Identifier:
NCT00576693
First received: December 7, 2007
Last updated: June 10, 2014
Last verified: June 2014
Results First Received: May 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Ischemic Stroke
Interventions: Device: intracranial angioplasty and stenting
Other: intensive medical management

  Participant Flow
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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
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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


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 ( US NIH Grant/Contract Award Number )
Study First Received: December 7, 2007
Results First Received: May 6, 2014
Last Updated: June 10, 2014
Health Authority: United States: Food and Drug Administration