Risk Factor Control Before Orthopedic Surgery

NCT01837069 | Terminated Phase 4 Results DMC FDA Drug

• 1 other identifier: 12-02407
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.

Conditions

Osteoarthritis; Cardiovascular Disease

Keywords

Hypertension; Diabetes; Coronary Artery Disease; Peripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

• Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism

  30 days

Secondary Outcomes (1)

• Modified Composite of Cardiovascular Events

  30 days

Other Outcomes (2)

• Length of Stay

  Hospital stay, ~7 days

• Each Individual Endpoint of the Composite of Cardiovascular Events

  30 days

Study Arms (2)

Treatment

ACTIVE COMPARATOR

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

Drug: Metoprolol; Drug: Lisinopril; Drug: Atorvastatin; Behavioral: Lifestyle counseling

Control

NO INTERVENTION

Standard of care

Interventions

Metoprolol DRUG

25mg PO BID if the HR is elevated at preadmission testing

Also known as: Beta blocker

Treatment

Lisinopril DRUG

2.5mg PO QD if the HR is elevated at preadmission testing

Also known as: ACE inhibitor

Treatment

Atorvastatin DRUG

80mg PO QD at preadmission testing

Also known as: Statin

Treatment

Lifestyle counseling BEHAVIORAL

Diet, exercise, medication adherance and smoking counseling

Treatment

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 21 years of age
• Subjects undergoing open orthopedic surgery of the hip, knee or spine
• Surgery is scheduled at least 3 days after PAT visit and no more than 14 days.
• High risk subject cohort
• Coronary artery disease, or
• Cerebrovascular disease (prior stroke, TIA or carotid artery disease (\>70% stenosis), or
• Peripheral artery disease, or
• Prior Venous thromboembolism or arterial thromboembolism, or
• Age ≥ 60 years and 2 of the following
• Renal insufficiency (creatinine clearance \< 60ml/min)
• Diabetes
• COPD
• Hypertension
• Active smoker or stopped less than 30 days prior to consent
• Cancer (excluding BCC)

You may not qualify if:

• Known intolerance to statins
• Subject is already on maximum dose statin (atorvastatin/Lipitor 80mg daily or rosuvastatin/crestor 40mg daily)
• Bilateral renal artery stenosis
• End stage renal disease (receiving dialysis or CrCl \<30ml/min)
• Known allergy or intolerance to ACE-inhibitor (other than cough) or Angiotensin receptor blocker (e.g. angioedema, hyperkalemia)
• Known allergy or intolerance to beta blockers
• Known sick sinus syndrome not treated with permanent pacemaker
• Known greater than first degree AV block not treated with a pacemaker
• Excessive alcohol intake
• Acute Coronary Syndrome requiring hospitalization within 1 month
• Stroke within 1 month
• Known pregnancy
• Severe co-morbid condition with life expectancy \< 6 months
• Inability to give informed consent or adhere to follow-up as per protocol
• Current participation in another investigational drug or device trial

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Hospital for Joint Diseases

New York, New York, 10003, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Cardiovascular Diseases; Hypertension; Diabetes Mellitus; Coronary Artery Disease; Peripheral Vascular Diseases

Interventions

Metoprolol; Adrenergic beta-Antagonists; Lisinopril; Angiotensin-Converting Enzyme Inhibitors; Atorvastatin; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Coronary Disease; Myocardial Ischemia; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Protease Inhibitors; Enzyme Inhibitors; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Lipid Regulating Agents; Therapeutic Uses

Results Point of Contact

• Title: Jeffrey Berger
• Organization: NYU Langone Health

Jeffrey.Berger@nyulangone.org

212 263 4004

Study Officials

• Jeffrey Berger, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2013
• First Posted: April 22, 2013
• Study Start: February 1, 2014
• Primary Completion: April 2, 2018
• Study Completion: April 2, 2018
• Last Updated: July 27, 2020
• Results First Posted: July 27, 2020

Record last verified: 2020-07

Locations

US (1)