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Trial record 32 of 101 for:    "thoracic aortic aneurysms and aortic dissections" OR "Aortic Aneurysm, Thoracic"

Study of GSK1278863 to Reduce Ischemic Events in Patients Undergoing Thoracic Aortic Aneurysm Repair

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ClinicalTrials.gov Identifier: NCT01920594
Recruitment Status : Completed
First Posted : August 12, 2013
Results First Posted : December 7, 2017
Last Update Posted : December 7, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Surgical Procedures
Interventions: Drug: GSK1278863
Drug: Placebo

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This study was conducted across 10 centers in the United States and 2 centers in Canada from 31 October 2013 to 08 October 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 55 participants were randomized in the study and were included in All Subjects Population. Participants were stratified according to intervention type (surgical or endovascular repair, with the latter limited to 50% of the total study population).

Reporting Groups
  Description
GSK1278863 300 mg Loading + 100 mg QD Eligible participants received GSK1278863 300 milligrams (mg) on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg once daily (QD) for 4 days starting from Day 0 (surgical day).
Placebo Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).

Participant Flow:   Overall Study
    GSK1278863 300 mg Loading + 100 mg QD   Placebo
STARTED   27   28 
COMPLETED   20   25 
NOT COMPLETED   7   3 
Adverse Event                4                2 
Lost to Follow-up                1                0 
Recovery                2                0 
Investigator discretion                0                1 



  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
GSK1278863 300 mg Loading + 100 mg QD Eligible participants received GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
Placebo Eligible participants received Placebo matching GSK1278863 300 mg on Day -1 (12 +/- 4 hours prior to planned surgery) as a loading dose followed by Placebo matching GSK1278863 100 mg QD for 4 days starting from Day 0 (surgical day).
Total Total of all reporting groups

Baseline Measures
   GSK1278863 300 mg Loading + 100 mg QD   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   28   55 
Age, Customized 
[Units: Participants]
Count of Participants
     
21 to 88 years   27   28   55 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9  33.3%      10  35.7%      19  34.5% 
Male      18  66.7%      18  64.3%      36  65.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1   3.7%      2   7.1%      3   5.5% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      2   7.4%      7  25.0%      9  16.4% 
White      24  88.9%      19  67.9%      43  78.2% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 


  Outcome Measures

1.  Primary:   Change From Baseline to Peak in Cerebrospinal Fluid (CSF) S100 Beta Within 48 Hours Following Descending Thoracic Aorta/Thoracoabdominal Aortic Aneurysm (DTA/TAAA) Repair   [ Time Frame: Baseline (Day 0) to 48 hours following DTA/TAAA repair ]

2.  Primary:   Change From Baseline to Peak in CSF Glial Fibrillary Acidic Protein (GFAP) Within 48 Hours Following DTA/TAAA Repair   [ Time Frame: Baseline (Day 0) to 48 hours following DTA/TAAA repair ]

3.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to Follow-up (Day 45) ]

4.  Secondary:   Number of Participants With Vital Signs of Potential Clinical Importance (PCI)   [ Time Frame: Up to Follow-up (Day 45) ]

5.  Secondary:   Number of Participants With Abnormal Electrocardiography (ECG) Parameters   [ Time Frame: Up to Follow-up (Day 45) ]

6.  Secondary:   Number of Participants With Clinical Chemistry Parameters of PCI   [ Time Frame: Up to post-operative Day 7 ]

7.  Secondary:   Number of Participants With Hematology Parameters of PCI   [ Time Frame: Up to post-operative Day 7 ]

8.  Secondary:   Change From Baseline in Area Under Curve (AUC) for CSF S100 Beta to 48 Hours   [ Time Frame: Baseline(Day 0) to 48 hours following DTA/TAAA repair ]

9.  Secondary:   Change From Baseline in AUC for CSF GFAP to 48 Hours   [ Time Frame: Baseline(Day 0) to 48 hours following DTA/TAAA repair ]

10.  Secondary:   Change From Baseline to Peak in CSF Biomarker Erythropoietin Within 48 Hours Following DTA/TAAA Repair   [ Time Frame: Baseline (Day 0) to 48 hours following DTA/TAAA repair ]

11.  Secondary:   Change From Baseline to Peak in CSF Biomarker Lactate Dehydrogenase Within 48 Hours Following DTA/TAAA Repair   [ Time Frame: Baseline (Day 0) to 48 hours following DTA/TAAA repair ]

12.  Secondary:   Change From Baseline to Peak in CSF Biomarker Tau Protein Within 48 Hours Following DTA/TAAA Repair   [ Time Frame: Baseline (Day 0) to 48 hours following DTA/TAAA repair ]

13.  Secondary:   Change From Baseline to Peak in CSF Biomarker Neuron-specific Enolase (NSE) Within 48 Hours Following DTA/TAAA Repair   [ Time Frame: Baseline (Day 0) to 48 hours following DTA/TAAA repair ]

14.  Secondary:   Number of Participants With Neurologic Outcomes Assessed by the National Institutes of Health Stroke Scale (NIHSS)   [ Time Frame: Surgical Day (Day 0), Post-operative Day 1, 2, 7 and follow-up (Day 45) ]

15.  Secondary:   Number of Participants With Neurologic Outcomes Assessed by Modified Rankin Scale (mRS)   [ Time Frame: Post-operative Day 7 and follow-up (Day 45) ]

16.  Secondary:   Number of Participants With Neurologic Outcomes Assessed by the American Spinal Injury Association (ASIA) Lower Extremity Motor Outcome Scale   [ Time Frame: Surgical Day (Day 0), Post-operative Day 1, 2, 7 and follow-up (Day 45) ]

17.  Secondary:   Number of Participants With Clinical Composite of All Cause Mortality, Stroke, Spinal Infarction, MI, Need for Dialysis/Sustained Doubling of Serum Creatinine   [ Time Frame: Up to Follow-up (Day 45) ]

18.  Secondary:   Assessment in AUC for Markers of Ischemic Organ Injury Including Tropinin Within 48 Hours   [ Time Frame: Baseline (Day 0) and 8 to 48 hours following DTA/TAAA repair ]

19.  Secondary:   Number of Participants With Composite Index of All Cause Mortality and Disability (NIHSS>5/ASIA<40)   [ Time Frame: Up to Follow-up (Day 45) ]

20.  Secondary:   Pharmacokinetic (PK) Parameters in Blood: AUC(0-t) of GSK1278863   [ Time Frame: Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3 ]

21.  Secondary:   PK Parameters in CSF: AUC(0-t) of GSK1278863   [ Time Frame: Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI ]

22.  Secondary:   PK Parameters in Blood: Maximum Observed Concentration (Cmax) of GSK1278863   [ Time Frame: Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3 ]

23.  Secondary:   PK Parameters in CSF: Cmax of GSK1278863   [ Time Frame: Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI ]

24.  Secondary:   PK Parameters in Blood: Time of Occurrence of Cmax (Tmax) of GSK1278863   [ Time Frame: Pre-dose, 1 to 3 hours post-dose, every 5 hours for 24 hours, 1, 3, 8 and 24 hours post-dose on Day 1 and 3 ]

25.  Secondary:   PK Parameters in CSF: Tmax of GSK1278863   [ Time Frame: Prior to potential neurological ischemia (PNI), 2, 24, 36 and 48 hours post PNI ]


  Serious Adverse Events


  Other Adverse Events


  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

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01920594     History of Changes
Other Study ID Numbers: 116097
First Submitted: August 8, 2013
First Posted: August 12, 2013
Results First Submitted: September 18, 2017
Results First Posted: December 7, 2017
Last Update Posted: December 7, 2017