Trial Outcomes & Findings for Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients (NCT NCT02188121)
NCT ID: NCT02188121
Last Updated: 2023-01-30
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
227 participants
Primary outcome timeframe
Baseline to 12 months
Results posted on
2023-01-30
Participant Flow
23 participants were excluded after enrollment but prior to assignment to a study arm. The reasons for exclusion were vital signs or lab values outside of inclusion criteria, or emergence of details after enrollment that made participant ineligible.
Participant milestones
| Measure |
Statin and/or Angiotensin Receptor Blocker
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
Simvastatin: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
Losartan: Angiotensin II receptor antagonist
|
Usual Treatment
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
|
|---|---|---|
|
Overall Study
STARTED
|
99
|
105
|
|
Overall Study
COMPLETED
|
79
|
78
|
|
Overall Study
NOT COMPLETED
|
20
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fixed Dose Intervention Trial of New England Enhancing Survival in SMI Patients
Baseline characteristics by cohort
| Measure |
Statin and/or Angiotensin Receptor Blocker
n=99 Participants
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
Simvastatin: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
Losartan: Angiotensin II receptor antagonist
|
Usual Treatment
n=105 Participants
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.0 years
n=39 Participants
|
38.3 years
n=41 Participants
|
37.2 years
n=35 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=39 Participants
|
46 Participants
n=41 Participants
|
81 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=39 Participants
|
59 Participants
n=41 Participants
|
123 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=39 Participants
|
5 Participants
n=41 Participants
|
15 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=39 Participants
|
92 Participants
n=41 Participants
|
177 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
34 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
70 Participants
n=39 Participants
|
75 Participants
n=41 Participants
|
145 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
7 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
12 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=39 Participants
|
105 Participants
n=41 Participants
|
204 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 monthsOutcome measures
| Measure |
Statin and/or Angiotensin Receptor Blocker
n=99 Participants
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
Simvastatin: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
Losartan: Angiotensin II receptor antagonist
|
Usual Treatment
n=105 Participants
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
|
|---|---|---|
|
Number of Participants on Adequate Cardiovascular Prevention Care (Defined as Taking a Statin and Angiotensin Medication)
|
66 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Baseline to 12 monthsSimilar to secondary outcome measure but focusing on Low Density Lipoprotein, Systolic Blood Pressure, and Hemoglobin A1c
Outcome measures
| Measure |
Statin and/or Angiotensin Receptor Blocker
n=99 Participants
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
Simvastatin: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
Losartan: Angiotensin II receptor antagonist
|
Usual Treatment
n=105 Participants
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
|
|---|---|---|
|
Change in Low Density Lipoprotein Levels
Baseline
|
100 mg/dL
Interval 96.0 to 105.0
|
106 mg/dL
Interval 101.0 to 117.0
|
|
Change in Low Density Lipoprotein Levels
12 months
|
86 mg/dL
Interval 82.0 to 96.0
|
100 mg/dL
Interval 97.0 to 117.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3, 6, 9, and 12 monthsThe outcome here is the difference in summary risk level changes (e.g., modified Framingham score) between our two study groups, i.e., do intervention subjects experience differential changes in cardiovascular risk levels compared to control subjects. This outcome will be continuously measured (but not necessarily normally distributed).
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3, 6, 9, and 12 monthsSimilar to primary outcome measure, but here we count the number of distinct cardiovascular prevention drugs taken by the patient as a continuous measure to reflect potential for partial treatment.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3, 6, 9, and 12 monthsSimilar to secondary outcome measure but focusing on Systolic Blood Pressure
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline and 3, 6, 9, and 12 monthsSimilar to secondary outcome measure but focusing on Hemoglobin A1c
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 3 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 6 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 9 monthsOutcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 12 monthsOutcome measures
Outcome data not reported
Adverse Events
Statin and/or Angiotensin Receptor Blocker
Serious events: 7 serious events
Other events: 72 other events
Deaths: 1 deaths
Usual Treatment
Serious events: 4 serious events
Other events: 50 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Statin and/or Angiotensin Receptor Blocker
n=99 participants at risk
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
Simvastatin: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
Losartan: Angiotensin II receptor antagonist
|
Usual Treatment
n=105 participants at risk
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
|
|---|---|---|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/99 • 2 years per participant
|
0.95%
1/105 • 2 years per participant
|
|
Blood and lymphatic system disorders
Elevated creatine kinase level
|
2.0%
2/99 • 2 years per participant
|
0.00%
0/105 • 2 years per participant
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
1.0%
1/99 • 2 years per participant
|
0.00%
0/105 • 2 years per participant
|
|
Cardiac disorders
Hypotension
|
1.0%
1/99 • 2 years per participant
|
0.00%
0/105 • 2 years per participant
|
|
General disorders
Dehydration
|
1.0%
1/99 • 2 years per participant
|
0.00%
0/105 • 2 years per participant
|
|
Blood and lymphatic system disorders
Leukemia
|
1.0%
1/99 • 2 years per participant
|
0.00%
0/105 • 2 years per participant
|
|
General disorders
Placed on Lithium while on Losartan
|
1.0%
1/99 • 2 years per participant
|
0.00%
0/105 • 2 years per participant
|
|
Endocrine disorders
Diabetes
|
0.00%
0/99 • 2 years per participant
|
0.95%
1/105 • 2 years per participant
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/99 • 2 years per participant
|
1.9%
2/105 • 2 years per participant
|
Other adverse events
| Measure |
Statin and/or Angiotensin Receptor Blocker
n=99 participants at risk
Simvastatin 20mg PO daily and/or Losartan 25mg PO daily
Simvastatin: 3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
Losartan: Angiotensin II receptor antagonist
|
Usual Treatment
n=105 participants at risk
We will compare the initial treatment intervention with usual treatment (control arm), with both arms superimposed on a system of regular monitoring base. The investigators will make no effort to alter or influence treatment or use of that treatment for subjects in the control arm. Note that our goal in the Control arm is to characterize "usual treatment". We will not intervene in this care except in emergencies. Some patients who need care for metabolic syndrome may not be receiving it - just as they would if not in our trial.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization
|
23.2%
23/99 • 2 years per participant
|
19.0%
20/105 • 2 years per participant
|
|
General disorders
Medical Hospitalization
|
6.1%
6/99 • 2 years per participant
|
6.7%
7/105 • 2 years per participant
|
|
General disorders
Laboratory values outside normal range
|
43.4%
43/99 • 2 years per participant
|
21.9%
23/105 • 2 years per participant
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place