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Targeting Inflammation Using Salsalate in CardioVascular Disease (TINSAL-CVD)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00624923
First Posted: February 28, 2008
Last Update Posted: December 12, 2017
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:
Beth Israel Deaconess Medical Center
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joslin Diabetes Center
Results First Submitted: August 29, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Conditions: Coronary Artery Disease
Overweight
Interventions: Drug: Salsalate
Drug: Placebo

  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
340 subjects signed consent and were screened for eligibility.

Reporting Groups
  Description
1- Active Pharmacologic

Salsalate

Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months

2- Placebo

Placebo

Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months


Participant Flow:   Overall Study
    1- Active Pharmacologic   2- Placebo
STARTED   127   124 
COMPLETED   89   101 
NOT COMPLETED   38   23 



  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
1- Active Pharmacologic

Salsalate

Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months

2- Placebo

Placebo

Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months

Total Total of all reporting groups

Baseline Measures
   1- Active Pharmacologic   2- Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 127   124   251 
Age 
[Units: Years]
Mean (Standard Deviation)
 61.5  (6.8)   60.1  (7.2)   60.8  (7.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      9   7.1%      6   4.8%      15   6.0% 
Male      118  92.9%      118  95.2%      236  94.0% 
Region of Enrollment 
[Units: Participants]
     
United States   127   124   251 
Statin use 
[Units: Participants]
 126   122   248 


  Outcome Measures

1.  Primary:   Change in Non-calcified Plaque Volume in the Coronary Arteries Assessed by MDCTA From Baseline to 30 Months   [ Time Frame: Baseline to 30 months ]

2.  Secondary:   Change in the Metabolic Syndrome Assessed by Measures by Waist/Hip Ratio, Systolic and Diastolic Blood Pressure, Lipid Profiles (Total Cholesterol, Triglycerides, HDL and LDL), and Abdominal Adiposity Quantitated by Computerized Tomography   [ Time Frame: Baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

3.  Secondary:   Reduction of Mediators of Inflammation in the Circulation (Such as CRP), and Markers of Oxidative Stress.   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Reduction of Insulin Resistance Assessed by Fasting Insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Reduction of Inflammation in the Liver Associated With Nonalcoholic Steatohepatitis (NASH), and Reduction of Fatty Liver Quantitated by Computerized Tomography and Levels of AST and ALT as Markers of Liver Inflammation Related to NASH.   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Comparison of Rates of Addition of Anti-hypertensive, Diabetic, or Lipid Lowering Medication.   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Comparison of Numbers of Persons With Metabolic Syndrome Who Progress to Diabetes Between Groups.   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

8.  Secondary:   Comparison of Numbers of Persons Who Regress From ATPIII Metabolic Syndrome Criteria (for Those With Metabolic Syndrome at Baseline)   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

9.  Secondary:   Relationship Between Vitamin D Status and Coronary Calcification, as Well as With Insulin Resistance (HOMA-IR), Beta-cell Function (HOMA-%Beta), and Serum Levels of Inflammatory Cytokines and Adhesion Molecules, Known to be Related to CVD Risk.   [ Time Frame: Baseline evaluation ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

10.  Secondary:   Determination of Whether Baseline Vitamin D Levels Predict Clinical Response to Salsalate, and Whether Hypovitaminosis D is Associated With Plaque Progression.   [ Time Frame: baseline to 30 mo ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Dr. Allison Goldfine
Organization: Joslin Diabetes Center
phone: 617-309-2400
e-mail: allison.goldfine@joslin.harvard.edu


Publications of Results:
Other Publications:


Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00624923     History of Changes
Other Study ID Numbers: CHS 06-13
P50HL083813 ( U.S. NIH Grant/Contract )
CCI: 2006-P-00175 ( Other Identifier: Beth Israel Deaconess Medical Center, Boston, MA, USA )
CHS: 06-13 ( Other Identifier: Joslin Diabetes Center, Boston, MA, USA )
First Submitted: February 19, 2008
First Posted: February 28, 2008
Results First Submitted: August 29, 2016
Results First Posted: December 12, 2017
Last Update Posted: December 12, 2017