Trial Outcomes & Findings for Targeting Inflammation Using Salsalate in CardioVascular Disease (NCT NCT00624923)

NCT ID: NCT00624923

Last Updated: 2019-05-07

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 340 participants
• Primary outcome timeframe: Baseline to 30 months
• Results posted on: 2019-05-07

Participant Flow

340 subjects signed consent and were screened for eligibility.

Participant milestones

Measure	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
Overall Study STARTED	127	124
Overall Study COMPLETED	89	101
Overall Study NOT COMPLETED	38	23

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Targeting Inflammation Using Salsalate in CardioVascular Disease

Baseline characteristics by cohort

Measure	1- Active Pharmacologic n=127 Participants Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2- Placebo n=124 Participants Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months	Total n=251 Participants Total of all reporting groups
Age, Continuous	61.5 years STANDARD_DEVIATION 6.8 • n=5 Participants	60.1 years STANDARD_DEVIATION 7.2 • n=7 Participants	60.8 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	118 Participants n=7 Participants	236 Participants n=5 Participants
Region of Enrollment United States	127 participants n=5 Participants	124 participants n=7 Participants	251 participants n=5 Participants
Statin use	126 participants n=5 Participants	122 participants n=7 Participants	248 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 30 months

Population: Intention to Treat

Outcome measures

Measure	1- Active Pharmacologic n=84 Participants Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2-Placebo n=89 Participants Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
Change in Non-calcified Plaque Volume in the Coronary Arteries Assessed by MDCTA From Baseline to 30 Months	0 mm^3 Interval -8.0 to 7.0	0 mm^3 Interval -7.0 to 7.0

SECONDARY outcome

Timeframe: Baseline to 30 mo

secondary

Outcome measures

Measure	1- Active Pharmacologic n=127 Participants Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2-Placebo n=124 Participants Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
Change in Cholesterol	5.1 mg/dL Interval 1.2 to 9.0	2.0 mg/dL Interval -1.7 to 5.6

SECONDARY outcome

Timeframe: baseline to 30 mo

Secondary outcome of change in inflammation marker CRP

Outcome measures

Measure	1- Active Pharmacologic n=127 Participants Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2-Placebo n=124 Participants Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
Change in Inflammation Marker: CRP	-0.1 mg/L Interval -0.4 to 0.2	-0.1 mg/L Interval -0.4 to 0.1

SECONDARY outcome

Timeframe: baseline to 30 mo

Secondary outcome, change in liver inflammation associated with NASH: ALT

Outcome measures

Measure	1- Active Pharmacologic n=127 Participants Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2-Placebo n=124 Participants Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
Change in Inflammation in the Liver Associated With Nonalcoholic Steatohepatitis (NASH), ALT	-1.1 U/L Interval -2.1 to -0.1	-0.6 U/L Interval -1.6 to 0.4

Adverse Events

1- Active Pharmacologic

Serious events: 33 serious events

Other events: 127 other events

Deaths: 0 deaths

2- Placebo

Serious events: 32 serious events

Other events: 112 other events

Deaths: 0 deaths

Serious adverse events

Measure	1- Active Pharmacologic n=127 participants at risk Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2- Placebo n=124 participants at risk Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
Cardiac disorders Cardiac	10.2% 13/127 Standard FDA definitions of AE/SAE used.	15.3% 19/124 Standard FDA definitions of AE/SAE used.
Blood and lymphatic system disorders Vascular	2.4% 3/127 Standard FDA definitions of AE/SAE used.	1.6% 2/124 Standard FDA definitions of AE/SAE used.
Respiratory, thoracic and mediastinal disorders Pulmonary	1.6% 2/127 Standard FDA definitions of AE/SAE used.	2.4% 3/124 Standard FDA definitions of AE/SAE used.
Musculoskeletal and connective tissue disorders Musculoskeletal	3.9% 5/127 Standard FDA definitions of AE/SAE used.	3.2% 4/124 Standard FDA definitions of AE/SAE used.
Gastrointestinal disorders Gastrointestinal	3.1% 4/127 Standard FDA definitions of AE/SAE used.	4.8% 6/124 Standard FDA definitions of AE/SAE used.
Renal and urinary disorders Renal	3.9% 5/127 Standard FDA definitions of AE/SAE used.	0.00% 0/124 Standard FDA definitions of AE/SAE used.
Hepatobiliary disorders Hepatobiliary	0.79% 1/127 Standard FDA definitions of AE/SAE used.	0.81% 1/124 Standard FDA definitions of AE/SAE used.
Infections and infestations Infectious	2.4% 3/127 Standard FDA definitions of AE/SAE used.	0.81% 1/124 Standard FDA definitions of AE/SAE used.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	0.79% 1/127 Standard FDA definitions of AE/SAE used.	1.6% 2/124 Standard FDA definitions of AE/SAE used.
Skin and subcutaneous tissue disorders Dermatologic	0.79% 1/127 Standard FDA definitions of AE/SAE used.	0.00% 0/124 Standard FDA definitions of AE/SAE used.
General disorders General	2.4% 3/127 Standard FDA definitions of AE/SAE used.	1.6% 2/124 Standard FDA definitions of AE/SAE used.

Other adverse events

Measure	1- Active Pharmacologic n=127 participants at risk Salsalate Salsalate: Salsalate, 500 mg, seven tablets daily by mouth, divided into two doses, for 30 months	2- Placebo n=124 participants at risk Placebo Placebo: Salsalate Placebo, seven tablets daily by mouth, divided into two doses, for 30 months
Ear and labyrinth disorders Ear and Labyrinth	27.6% 35/127 Standard FDA definitions of AE/SAE used.	10.5% 13/124 Standard FDA definitions of AE/SAE used.
General disorders General	13.4% 17/127 Standard FDA definitions of AE/SAE used.	10.5% 13/124 Standard FDA definitions of AE/SAE used.
Gastrointestinal disorders Gastrointestinal	11.8% 15/127 Standard FDA definitions of AE/SAE used.	7.3% 9/124 Standard FDA definitions of AE/SAE used.
Respiratory, thoracic and mediastinal disorders Respiratory	50.4% 64/127 Standard FDA definitions of AE/SAE used.	43.5% 54/124 Standard FDA definitions of AE/SAE used.
Respiratory, thoracic and mediastinal disorders Dyspnea	16.5% 21/127 Standard FDA definitions of AE/SAE used.	12.1% 15/124 Standard FDA definitions of AE/SAE used.
Gastrointestinal disorders Mouth sores	10.2% 13/127 Standard FDA definitions of AE/SAE used.	6.5% 8/124 Standard FDA definitions of AE/SAE used.

Additional Information

Dr. Allison Goldfine

Joslin Diabetes Center

Phone: 617-309-2400

Email: allison.goldfine@joslin.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place