Trial Outcomes & Findings for Risk Factor Control Before Orthopedic Surgery (NCT NCT01837069)

NCT ID: NCT01837069

Last Updated: 2020-07-27

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 198 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2020-07-27

Participant Flow

Participant milestones

Measure	Treatment Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling	Control Standard of care
Overall Study STARTED	103	95
Overall Study COMPLETED	103	95
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Risk Factor Control Before Orthopedic Surgery

Baseline characteristics by cohort

Measure	Treatment n=103 Participants Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling	Control n=95 Participants Standard of care	Total n=198 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=93 Participants	95 Participants n=4 Participants	198 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	56 Participants n=93 Participants	44 Participants n=4 Participants	100 Participants n=27 Participants
Sex: Female, Male Male	47 Participants n=93 Participants	51 Participants n=4 Participants	98 Participants n=27 Participants
Race/Ethnicity, Customized Asian	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Race/Ethnicity, Customized Black or African American	14 Participants n=93 Participants	12 Participants n=4 Participants	26 Participants n=27 Participants
Race/Ethnicity, Customized White	80 Participants n=93 Participants	74 Participants n=4 Participants	154 Participants n=27 Participants
Race/Ethnicity, Customized Hispanic or Latino	10 Participants n=93 Participants	11 Participants n=4 Participants	21 Participants n=27 Participants
Race/Ethnicity, Customized # Unknown or not reported	6 Participants n=93 Participants	6 Participants n=4 Participants	12 Participants n=27 Participants
Region of Enrollment United States	103 participants n=93 Participants	95 participants n=4 Participants	198 participants n=27 Participants

PRIMARY outcome

Timeframe: 30 days

Outcome measures

Measure	Treatment n=103 Participants Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling	Control n=95 Participants Standard of care
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism	10 participants	2 participants

SECONDARY outcome

Timeframe: 30 days

Population: No data are available for this Outcome Measure. Multiple efforts were made to obtain the data from the PI but were unsuccessful, therefore, data cannot be reported.

the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Hospital stay, ~7 days

Outcome measures

Measure	Treatment n=93 Participants Lifestyle counseling (nutrition, physical activity, medication compliance and smoking cessation) Atorvastatin 80mg PO QD Metoprolol 25mg PO BID if HR is elevated Lisinopril 2.5 mg PO QD if SBP is elevated Metoprolol: 25mg PO BID if the HR is elevated at preadmission testing Lisinopril: 2.5mg PO QD if the HR is elevated at preadmission testing Atorvastatin: 80mg PO QD at preadmission testing Lifestyle counseling: Diet, exercise, medication adherance and smoking counseling	Control n=89 Participants Standard of care
Length of Stay	3 days Interval 2.0 to 4.0	3 days Interval 2.0 to 3.75

OTHER_PRE_SPECIFIED outcome

Timeframe: 30 days

Population: Efforts were made to collect this data from PI, but data analysis was not completed for this outcome measure

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jeffrey Berger

NYU Langone Health

Phone: 212 263 4004

Email: Jeffrey.Berger@nyulangone.org

Results disclosure agreements

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