ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00624923
Recruitment Status : Active, not recruiting
First Posted : February 28, 2008
Results First Posted : December 12, 2017
Last Update Posted : December 12, 2017
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Tufts Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Joslin Diabetes Center

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
Enrollment 340
Recruitment Details  
Pre-assignment Details 340 subjects signed consent and were screened for eligibility.
Arm/Group Title 1- Active Pharmacologic 2- Placebo
Hide Arm/Group Description

Salsalate

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

Placebo

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

Period Title: Overall Study
Started 127 124
Completed 89 101
Not Completed 38 23
Arm/Group Title 1- Active Pharmacologic 2- Placebo Total
Hide Arm/Group Description

Salsalate

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

Placebo

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

Total of all reporting groups
Overall Number of Baseline Participants 127 124 251
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 127 participants 124 participants 251 participants
61.5  (6.8) 60.1  (7.2) 60.8  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 127 participants 124 participants 251 participants
Female
9
   7.1%
6
   4.8%
15
   6.0%
Male
118
  92.9%
118
  95.2%
236
  94.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 127 participants 124 participants 251 participants
127 124 251
Statin use  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 127 participants 124 participants 251 participants
126 122 248
1.Primary Outcome
Title Change in Non-calcified Plaque Volume in the Coronary Arteries Assessed by MDCTA From Baseline to 30 Months
Hide Description [Not Specified]
Time Frame Baseline to 30 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intention to Treat
Arm/Group Title 1- Active Pharmacologic 2-Placebo
Hide Arm/Group Description:

Salsalate

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

Placebo

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

Overall Number of Participants Analyzed 84 89
Mean (95% Confidence Interval)
Unit of Measure: mm^3
0
(-8 to 7)
0
(-7 to 7)
2.Secondary Outcome
Title 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
Hide Description [Not Specified]
Time Frame Baseline to 30 mo
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Reduction of Mediators of Inflammation in the Circulation (Such as CRP), and Markers of Oxidative Stress.
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Reduction of Insulin Resistance Assessed by Fasting Insulin and Homeostasis Model Assessment of Insulin Resistance (HOMA-IR).
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
5.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Comparison of Rates of Addition of Anti-hypertensive, Diabetic, or Lipid Lowering Medication.
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
7.Secondary Outcome
Title Comparison of Numbers of Persons With Metabolic Syndrome Who Progress to Diabetes Between Groups.
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Comparison of Numbers of Persons Who Regress From ATPIII Metabolic Syndrome Criteria (for Those With Metabolic Syndrome at Baseline)
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
9.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame Baseline evaluation
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Determination of Whether Baseline Vitamin D Levels Predict Clinical Response to Salsalate, and Whether Hypovitaminosis D is Associated With Plaque Progression.
Hide Description [Not Specified]
Time Frame baseline to 30 mo
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1- Active Pharmacologic 2- Placebo
Hide Arm/Group Description

Salsalate

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

Placebo

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

All-Cause Mortality
1- Active Pharmacologic 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
1- Active Pharmacologic 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   33/127 (25.98%)   32/124 (25.81%) 
Blood and lymphatic system disorders     
Vascular  3/127 (2.36%)  2/124 (1.61%) 
Cardiac disorders     
Cardiac  13/127 (10.24%)  19/124 (15.32%) 
Gastrointestinal disorders     
Gastrointestinal  4/127 (3.15%)  6/124 (4.84%) 
General disorders     
General  3/127 (2.36%)  2/124 (1.61%) 
Hepatobiliary disorders     
Hepatobiliary  1/127 (0.79%)  1/124 (0.81%) 
Infections and infestations     
Infectious  3/127 (2.36%)  1/124 (0.81%) 
Musculoskeletal and connective tissue disorders     
Musculoskeletal  5/127 (3.94%)  4/124 (3.23%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm  1/127 (0.79%)  2/124 (1.61%) 
Renal and urinary disorders     
Renal  5/127 (3.94%)  0/124 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary  2/127 (1.57%)  3/124 (2.42%) 
Skin and subcutaneous tissue disorders     
Dermatologic  1/127 (0.79%)  0/124 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1- Active Pharmacologic 2- Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   127/127 (100.00%)   112/124 (90.32%) 
Ear and labyrinth disorders     
Ear and Labyrinth  35/127 (27.56%)  13/124 (10.48%) 
Gastrointestinal disorders     
Gastrointestinal  15/127 (11.81%)  9/124 (7.26%) 
Mouth sores  13/127 (10.24%)  8/124 (6.45%) 
General disorders     
General  17/127 (13.39%)  13/124 (10.48%) 
Respiratory, thoracic and mediastinal disorders     
Respiratory  64/127 (50.39%)  54/124 (43.55%) 
Dyspnea  21/127 (16.54%)  15/124 (12.10%) 
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
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