Myocardial Injury After Noncardiac SurgeryEarly Phase 1NCT06961630
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction
A Early Phase 1 study testing Rivaroxaban and Atorvastatin in people with Myocardial Injury After Noncardiac Surgery, run by NYU Langone Health at 1 site in United States.
Trial summary
The goal of this pilot study is to assess enrollment feasibility of a randomized trial of direct oral anticoagulant and high-intensity statin therapy versus usual care in patients with Myocardial Injury after Noncardiac Surgery (MINS). Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Myocardial Injury After Noncardiac Surgery
- What is being tested?
- Rivaroxaban and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Oct 2025to 31 Mar 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥45 years
- Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days
- Myocardial injury after noncardiac surgery, defined as a post-operative troponin ≥ 99th percentile upper reference limit [URL], with rise/fall >20% indicative of acute myocardial injury.
- Ability to provide informed consent
Who cannot join
- Expected survival <6 months
- Hemorrhagic disorder
- Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery
- Indication for oral anticoagulation at discharge
- Indication for dual antiplatelet therapy at discharge
- Patient already receiving or planned to receive moderate or high-intensity statin
Show all 11Show fewer
- Contraindication to high-intensity statin
- Contraindication to rivaroxaban
- End stage kidney disease on hemodialysis
- Acute liver failure or decompensated cirrhosis
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
The goal of this pilot study is to assess enrollment feasibility of a randomized trial of direct oral anticoagulant and high-intensity statin therapy versus usual care in patients with Myocardial Injury after Noncardiac Surgery (MINS). The primary aims of this study are to assess feasibility, study drug adherence, and optimize study design (entry criteria, study endpoints, sample size calculation, site selection) and recruitment strategies for the future multicenter randomized clinical trial studying biomarker-based care in post-operative patients at elevated cardiovascular (CV) risk.
- Being tested
- Rivaroxaban, Atorvastatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.
AtorvastatinDrug
Atorvastatin 80mg will be orally administered daily for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| Rivaroxaban + Atorvastatin | Experimental | Participants assigned to this arm will receive rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily for 6 months. Receives: Drug: Rivaroxaban; Drug: Atorvastatin |
| Usual Care | No intervention | Participants assigned to usual care will continue all clinically indicated therapies as prescribed by their treating physicians. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of pills taken at Month 6
Treatment adherence will be assessed by pill count and patient self report.
Measured: Month 6
Secondary outcomes (1)
Percentage of Quality of Life (QOL) questionnaires completed at Month 6
Two QOL questionnaires (Patient-Reported Outcomes Measurement Information System Global-10 (PROMIS-10) and EuroQol 5 Dimension (EQ5D)) will be administered at baseline, 2-month follow-up visit, and the 6-month follow-up visit.
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2025
- Study start7 Oct 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Injury After Noncardiac SurgeryStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nathaniel R. Smilowitz, MD, MS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06961630
- Sponsor's protocol ID
- 24-01260
- Other IDs
- 1R34HL173301-01A1
- Status last verified
- Mar 2026
- First submitted
- 6 May 2025
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared for any purpose immediately following publication. No end date. Data are available indefinitely at: NHLBI BioData Catalyst (BDC), an existing NIH-supported Scientific Data Repository. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized Trial of Post-Operative Biomarker-Guided Precision Medicine With Rivaroxaban and Atorvastatin for Cardiovascular Risk-Reduction
- ClinicalTrials.gov ID
- NCT06961630
- Acronym / sponsor ID
- 24-01260
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 7 Oct 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this pilot study is to assess enrollment feasibility of a randomized trial of direct oral anticoagulant and high-intensity statin therapy versus usual care in patients with Myocardial Injury after Noncardiac Surgery (MINS). The primary aims of this study are to assess feasibility, study drug adherence, and optimize study design (entry criteria, study endpoints, sample size calculation, site selection) and recruitment strategies for the future multicenter randomized clinical trial studying biomarker-based care in post-operative patients at elevated cardiovascular (CV) risk.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rivaroxaban + Atorvastatin | Experimental | Drug: Rivaroxaban, Drug: AtorvastatinParticipants assigned to this arm will receive rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily for 6 months. |
| Usual Care | No intervention | –Participants assigned to usual care will continue all clinically indicated therapies as prescribed by their treating physicians. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥45 years
- Underwent major non-cardiac surgery requiring ≥1 overnight inpatient stay in the prior 14 days
- Myocardial injury after noncardiac surgery, defined as a post-operative troponin ≥ 99th percentile upper reference limit [URL], with rise/fall >20% indicative of acute myocardial injury.
- Ability to provide informed consent
Key exclusion criteria (11 listed)
- Expected survival <6 months
- Hemorrhagic disorder
- Surgeon feels it is unsafe to initiate low-dose anticoagulation within 14 days of surgery
- Indication for oral anticoagulation at discharge
- Indication for dual antiplatelet therapy at discharge
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 |
|---|---|---|
| RivaroxabanRivaroxaban 2.5mg will be orally administered twice daily for 6 months. | Drug | Rivaroxaban + Atorvastatin |
| AtorvastatinAtorvastatin 80mg will be orally administered daily for 6 months. | Drug | Rivaroxaban + Atorvastatin |
Primary outcome
Percentage of pills taken at Month 6
Time frame: Month 6
Treatment adherence will be assessed by pill count and patient self report.
1 secondary outcome
Percentage of Quality of Life (QOL) questionnaires completed at Month 6
Time frame: Month 6
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared for any purpose immediately following publication. No end date. Data are available indefinitely at: NHLBI BioData Catalyst (BDC), an existing NIH-supported Scientific Data Repository. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
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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.
Nathaniel R. Smilowitz, MD, MS principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Rivaroxaban and Atorvastatin in people with Myocardial Injury After Noncardiac Surgery, 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 4 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 6 Apr 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nathaniel Smilowitz (212-263-5656, Nathaniel.Smilowitz@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of pills taken at Month 6 (time frame: Month 6). 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 6 Apr 2026.