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

This study has been completed.
Sponsor:
Collaborators:
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
  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  
Number of Participants  
[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  
Diabetes [2]
[units: participants]
     
Yes     105     103     208  
No     119     124     243  
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 [3]
[units: % of the diameter the artery]
Mean ± Standard Deviation
  80  ± 7     81  ± 7     81  ± 7  
[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.

[2] A patient is considered diabetic at baseline if there is a history of diabetes or if the baseline hemoglobin A1c > 6.5%.
[3] 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
  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:


Responsible Party: Marc Chimowitz, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00576693     History of Changes
Other Study ID Numbers: R01NS058728-01A1, NINDS, CRC, 1U01NS058728-01A1
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