OsteoarthritisPhase 4OPTMIZE-OSNCT01837069
Risk Factor Control Before Orthopedic Surgery
A Phase 4 study testing Metoprolol, Lisinopril and Atorvastatin in people with Osteoarthritis and Cardiovascular Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Osteoarthritis, Cardiovascular Disease
- What is being tested?
- Metoprolol, Lisinopril and Atorvastatin
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 2 Apr 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • ≥ 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
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- 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)
- Heart Failure
Who cannot join
- • 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
NYU Hospital for Joint Diseases
New York, New York, 10003
About this study
Official title: Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery
This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.
Read the detailed description
OPTIMIZE - OS (Optimization of Pre-surgical Testing with an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events - Orthopedic Surgery) trial is to determine the best management strategy for patients undergoing orthopedic surgery. OPTIMIZE will be a prospective randomized trial that will enroll patients during pre-surgical testing before orthopedic surgery. This trial will investigate different strategies aimed at lowering cardiovascular events following orthopedic surgery. The study will compare an intensive multifactorial intervention comprising behavioral modification and polypharmacologic therapy aimed at several modifiable risk factors versus usual care. The trial hypothesis is that a personalized optimization approach is superior to usual care in reducing a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism or thrombosis requiring reoperation at 30-days. Secondary endpoints include length of stay, major bleeding, each individual endpoint from the primary endpoint, and quality of life.
- Conditions
- Osteoarthritis, Cardiovascular Disease
- Being tested
- Metoprolol, Lisinopril, Atorvastatin, Lifestyle counseling
- Keywords
- Hypertension, Diabetes, Coronary Artery Disease, Peripheral Vascular Disease
- Medical subject headings
- Osteoarthritis, Cardiovascular Diseases, Hypertension, Diabetes Mellitus, Coronary Artery Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoprololDrug
Also called Beta blocker
25mg PO BID if the HR is elevated at preadmission testing
LisinoprilDrug
Also called ACE inhibitor
2.5mg PO QD if the HR is elevated at preadmission testing
AtorvastatinDrug
Also called Statin
80mg PO QD at preadmission testing
Lifestyle counselingBehavioural
Diet, exercise, medication adherance and smoking counseling
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Metoprolol; Drug: Lisinopril; Drug: Atorvastatin; Behavioral: Lifestyle counseling |
| Control | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism
Measured: 30 days
Secondary outcomes (1)
Modified Composite of Cardiovascular Events
the reduction in the composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism, or reoperation
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startFeb 2014
- Primary completion2 Apr 2018
- Study completion2 Apr 2018
Why it stopped: Low recruitment / DSMB approval to halt recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Berger, MD, Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837069
- Sponsor's protocol ID
- 12-02407
- Acronym
- OPTMIZE-OS
- Status last verified
- Jul 2020
- First submitted
- 12 Apr 2013
- Last updated
- 27 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimization of Pre-surgical Testing With an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events in Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT01837069
- Acronym / sponsor ID
- OPTMIZE-OS / 12-02407
- Conditions
- Osteoarthritis, Cardiovascular Disease
- Keywords
- Hypertension, Diabetes, Coronary Artery Disease, Peripheral Vascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment / DSMB approval to halt recruitment
- Enrolment
- 198 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- 2 Apr 2018 (actual)
- Study completion
- 2 Apr 2018 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Posted 27 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.
Detailed description
OPTIMIZE - OS (Optimization of Pre-surgical Testing with an Intensive Multifactorial Intervention to MinimiZe Cardiovascular Events - Orthopedic Surgery) trial is to determine the best management strategy for patients undergoing orthopedic surgery. OPTIMIZE will be a prospective randomized trial that will enroll patients during pre-surgical testing before orthopedic surgery. This trial will investigate different strategies aimed at lowering cardiovascular events following orthopedic surgery. The study will compare an intensive multifactorial intervention comprising behavioral modification and polypharmacologic therapy aimed at several modifiable risk factors versus usual care. The trial hypothesis is that a personalized optimization approach is superior to usual care in reducing a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism or thrombosis requiring reoperation at 30-days. Secondary endpoints include length of stay, major bleeding, each individual endpoint from the primary endpoint, and quality of life.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Active comparator | Drug: Metoprolol, Drug: Lisinopril, Drug: Atorvastatin, Behavioral: Lifestyle counselingLifestyle 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 |
| Control | No intervention | –Standard of care |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- • ≥ 21 years of age
Key exclusion criteria (15 listed)
- • Known intolerance to statins
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoprololAlso: Beta blocker25mg PO BID if the HR is elevated at preadmission testing | Drug | Treatment |
| LisinoprilAlso: ACE inhibitor2.5mg PO QD if the HR is elevated at preadmission testing | Drug | Treatment |
| AtorvastatinAlso: Statin80mg PO QD at preadmission testing | Drug | Treatment |
| Lifestyle counselingDiet, exercise, medication adherance and smoking counseling | Behavioural | Treatment |
Primary outcome
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism
Time frame: 30 days
1 secondary outcome
Modified Composite of Cardiovascular Events
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Berger, MD principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metoprolol, Lisinopril and Atorvastatin in people with Osteoarthritis and Cardiovascular Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Partipants That Experienced Death, Myocardial Infarction, Stroke, Transient Ischemic Attack, Myocardial Necrosis, or Venous Thromboembolism (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2020.