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Carotid Occlusion Surgery Study (COSS)

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ClinicalTrials.gov Identifier: NCT00029146
Recruitment Status : Terminated (Pre-specified futility boundary was reached.)
First Posted : January 9, 2002
Results First Posted : March 26, 2012
Last Update Posted : March 27, 2012
Sponsor:
Collaborators:
National Institute of Neurological Disorders and Stroke (NINDS)
Washington University School of Medicine
University of Iowa
Information provided by (Responsible Party):
William Powers, University of North Carolina, Chapel Hill

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Stroke
Ischemic Attack, Transient
Cerebral Infarction
Interventions Procedure: extracranial-intracranial bypass surgery
Drug: best medical therapy
Enrollment 700
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy Receives best current practice medical therapy
Period Title: Overall Study
Started 97 98
Completed 95 97
Not Completed 2 1
Reason Not Completed
Lost to Follow-up             2             1
Arm/Group Title Surgical Group Non-surgical Group Total
Hide Arm/Group Description Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy Receives best current practice medical therapy Total of all reporting groups
Overall Number of Baseline Participants 97 98 195
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
76
  78.4%
71
  72.4%
147
  75.4%
>=65 years
21
  21.6%
27
  27.6%
48
  24.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 97 participants 98 participants 195 participants
58  (9) 58  (9) 58  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
Female
28
  28.9%
37
  37.8%
65
  33.3%
Male
69
  71.1%
61
  62.2%
130
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 97 participants 98 participants 195 participants
United States 93 94 187
Canada 4 4 8
1.Primary Outcome
Title Surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization
Hide Description 2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.
Time Frame within 2 yrs of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
21.0
(12.8 to 29.2)
22.7
(13.9 to 31.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference. The 2-sided z-statistic was compared to a standard unit normal distribution.The study was terminated early for futility after 195 of the planned 372 participants were enrolled.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 1.7
Confidence Interval 95%
-10.4 to 13.8
Estimation Comments Positive indicates lower rate in surgical group
2.Secondary Outcome
Title All Stroke
Hide Description 2 yr Kaplan-Meier estimates of the proportions. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours
Time Frame within 2 yrs of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.4
(14.8 to 32.0)
26.9
(17.6 to 36.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.59
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 3.5
Confidence Interval (2-Sided) 95%
-9.2 to 16.1
Estimation Comments Positive indicates lower rate in surgical group
3.Secondary Outcome
Title Disabling Stroke
Hide Description 2 yr Kaplan-Meier estimates of the proportions. Disabling stroke is defined as a modified Barthel Index of <12/20 at the first scheduled return visit more than 3 months after the stroke occurred
Time Frame within two years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
5.9
(0.8 to 10.4)
2.4
(0 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value -3.2
Confidence Interval (2-Sided) 95%
-9.0 to 2.6
Estimation Comments Negative indicates lower rate in non-surgical group
4.Secondary Outcome
Title Fatal Stroke
Hide Description 2 yr Kaplan-Meier estimates of the proportions. Fatal stroke is a stroke that in the investigator’s opinion led directly to the participants death within 30 days of occurrence
Time Frame within 2 years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.0
(0 to 3.1)
2.4
(0 to 5.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.50
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 1.3
Confidence Interval (2-Sided) 95%
-2.5 to 5.2
Estimation Comments Positive indicates lower rate in surgical group
5.Secondary Outcome
Title Death
Hide Description 2 yr Kaplan-Meier estimates of the proportions. Death of any cause
Time Frame within 2 years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
1.0
(0 to 3.1)
5.1
(0.2 to 9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 4.0
Confidence Interval (2-Sided) 95%
-1.2 to 9.7
Estimation Comments Positive indicates lower rate in surgical group
6.Secondary Outcome
Title Modified Rankin 0-1
Hide Description Proportion with modified Rankin score, dichotomized 0 or 1 vs 2-6.The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.
Time Frame at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
49.5
(39.5 to 59.4)
42.9
(33.1 to 52.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value -6.6
Confidence Interval (2-Sided) 95%
-20.6 to 7.3
Estimation Comments Negative indicates lower rate in non-surgical group. In this case, lower rate is worse since Rankin 0-1 indicates a good outcome.
7.Secondary Outcome
Title Modified Rankin 0-2
Hide Description Proportion with Modified Rankin score at 2 yrs, dichotomized 0-2 vs 3-6. The modifed Rankin (0-6) describes the degree of functional disability. A lower score indicates less functional disability.
Time Frame at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70.1
(61.0 to 79.2)
74.5
(65.9 to 83.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.70
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 4.4
Confidence Interval (2-Sided) 95%
-8.2 to 16.9
Estimation Comments Positive indicates lower rate in surgical group In this case, lower rate is worse since Rankin 0-2 indicates a good outcome.
8.Secondary Outcome
Title Modified Barthel Index 19-20
Hide Description Modified Barthel Index dichotomized 19-20 vs <= 18. The modifed Barthel Index(0-20) describes the degree of independence in day-to-day self-care activities. A higher score indicates greater independence.
Time Frame at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Unit of Measure: percentage of participants
70.1 71.4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.85
Comments [Not Specified]
Method Fisher's Exact Test
Comments [Not Specified]
9.Secondary Outcome
Title Summary SS-QOL Score
Hide Description Summary Stroke Specific Quality of Life score (1-4) askes how self-reported overall quality of life compares with with that before stroke. A higher score indicates is better.
Time Frame at 2 years after randomization or end of trial. Worst case imputed for death and missing values
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
3.82
(3.60 to 4.04)
3.58
(3.37 to 3.79)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.13
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.24
Confidence Interval (2-Sided) 95%
-0.54 to 0.07
Estimation Comments Negative indicates lower score in non-surgical group.A higher score indicates better quality of life
10.Secondary Outcome
Title Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-surgery; Non-surgical Group:Ipsilateral Ischemic Stroke in 2 Yrs From Randomization and All Stroke & Death Through 30d Post-randomization
Hide Description 2 yr Kaplan-Meier estimates of the proportions.Proportions expressed as percentages for reporting purposes. Ipsilateral ischemic stroke is defined as the clinical diagnosis of a focal neurological deficit due to cerebral ischemia clinically localizable within the internal carotid artery territory distally to the symptomatic occluded internal carotid artery that lasts for more than 24 hours. All stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.
Time Frame within 2 years of randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
On-treatment analysis removing four participants assigned to the surgical group who never underwent surgery and censoring on the day of surgery three participants assigned to the nonsurgical group who underwent EC-IC bypass surgery.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 93 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
20.8
(12.4 to 29.1)
22.3
(13.3 to 31.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.81
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 1.5
Confidence Interval (2-Sided) 95%
-10.7 to 13.7
Estimation Comments [Not Specified]
11.Other Pre-specified Outcome
Title Any Stroke or Death Within 30 Days After Surgery
Hide Description [Not Specified]
Time Frame within 30 days after surgery
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat. All assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Arm/Group Title Surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Overall Number of Participants Analyzed 97
Measure Type: Number
Unit of Measure: participants
14
12.Post-Hoc Outcome
Title Any Stroke or Death
Hide Description 2 yr Kaplan-Meier estimates of the proportions. Any stroke is defined as the clinical diagnosis of a focal deficit due to ischemia or hemorrhage clinically localizable to the brain that lasts for more than 24 hours. Death is of any cause.
Time Frame within 2 years after randomization
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to treat principle.All participants analyzed in the group to which they were originally randomized.
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description:
Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
Receives best current practice medical therapy
Overall Number of Participants Analyzed 97 98
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
23.4
(14.8 to 32.0)
29.9
(20.1 to 39.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Surgical Group, Non-surgical Group
Comments Rates for each group were based on product limit estimates of 2-year rates and their standard errors. The test statistic was calculated as the difference in estimated rates divided by the standard error of that difference.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .33
Comments [Not Specified]
Method 2-sided z-statistic
Comments The difference in estimated rates divided by the standard error of that difference was compared to a standard unit normal distribution.
Method of Estimation Estimation Parameter Difference in estimated 2 yr rates
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
-6.5 to 19.6
Estimation Comments Positive indicates lower rate in surgical group
Time Frame Surgical group: Within 30 days after surgery for 93 operated and within 30 days after randomization for 4 not operated Non-surgical group: Within 30 days after randomization
Adverse Event Reporting Description Only serious adverse events were assessed
 
Arm/Group Title Surgical Group Non-surgical Group
Hide Arm/Group Description Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy Receives best current practice medical therapy
All-Cause Mortality
Surgical Group Non-surgical Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Surgical Group Non-surgical Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14/97 (14.43%)      2/98 (2.04%)    
Blood and lymphatic system disorders     
Deep venous thrombosis   1/97 (1.03%)  1 0/98 (0.00%)  0
Pulmonary embolism   1/97 (1.03%)  1 0/98 (0.00%)  0
Cardiac disorders     
Hypotension   1/97 (1.03%)  1 0/98 (0.00%)  0
Myocardial ischemia/infarction   1/97 (1.03%)  1 0/98 (0.00%)  0
Atrial fibrillation/flutter   1/97 (1.03%)  1 0/98 (0.00%)  0
Endocrine disorders     
Hypoglycemia   1/97 (1.03%)  1 0/98 (0.00%)  0
Nervous system disorders     
Fatal stroke   1/97 (1.03%)  1 0/98 (0.00%)  0
Non-fatal Stroke   13/97 (13.40%)  13 2/98 (2.04%)  2
Transient ischemic attack   4/97 (4.12%)  4 0/98 (0.00%)  0
Epidural/subdural hematoma   2/97 (2.06%)  2 0/98 (0.00%)  0
Seizure   2/97 (2.06%)  2 0/98 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Respiratory distress   2/97 (2.06%)  2 0/98 (0.00%)  0
Surgical and medical procedures     
Surgical site infection   1/97 (1.03%)  1 0/98 (0.00%)  0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Surgical Group Non-surgical Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/0      0/0    
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: William J. Powers, MD
Organization: University of North Carolina at Chapel HIll
Responsible Party: William Powers, University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT00029146     History of Changes
Other Study ID Numbers: R01NS042167
R01NS041895 ( Other Grant/Funding Number: NINDS )
First Submitted: January 8, 2002
First Posted: January 9, 2002
Results First Submitted: January 17, 2012
Results First Posted: March 26, 2012
Last Update Posted: March 27, 2012