Post-Operative Biomarker-Guided Precision Medicine For Ca... | NCT06961630

Studies
Post-Operative Biomarker-Guided Precision Medicine For Cardiovascular Risk Reduction

NCT06961630

Sponsor

NYU Langone Health

Status

Recruiting

Last Update Posted

Apr 6, 2026Actual

Enrollment

50Estimated

Phase

Early Phase 1

Conditions

Myocardial Injury After Noncardiac Surgery

Interventions

Rivaroxaban
Atorvastatin

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R34HL173301-01A1	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 7, 2025Actual

Primary Completion Date

Mar 31, 2027Estimated

Completion Date

Mar 31, 2027Estimated

First Submitted Date

May 6, 2025

First Submission Date that Met QC Criteria

May 6, 2025

First Posted Date

May 8, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 6, 2026Actual

Name	Class
National Heart, Lung, and Blood Institute (NHLBI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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). 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Early Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rivaroxaban + Atorvastatin	Experimental	Participants assigned to this arm will receive rivaroxaban 2.5mg twice daily + atorvastatin 80mg daily for 6 months.	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rivaroxaban	Drug	Rivaroxaban 2.5mg will be orally administered twice daily for 6 months.	Rivaroxaban + Atorvastatin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of pills taken at Month 6	Treatment adherence will be assessed by pill count and patient self report.	Month 6

Secondary Outcomes

Measure	Description	Time Frame
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.	Month 6

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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
Contraindication to high-intensity statin
Contraindication to rivaroxaban
End stage kidney disease on hemodialysis
Acute liver failure or decompensated cirrhosis
Pregnancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Nathaniel Smilowitz	Contact	212-263-5656		Nathaniel.Smilowitz@nyulangone.org

Overall Officials

Name	Affiliation	Role
Nathaniel R. Smilowitz, MD, MS	NYU Langone Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NYU Langone Health	Recruiting	New York	New York	10016	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Immediately following publication. No end date.

Access Criteria

Data are available indefinitely for anyone who wishes to access the data for any purpose at: NHLBI BioData Catalyst (BDC), an existing NIH-supported Scientific Data Repository.

URL

https://biodatacatalyst.nhlbi.nih.gov/

Intervention Browse Module

MeSH Terms

ID	Term
D000069552	Rivaroxaban
D000069059	Atorvastatin

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D009025	Morpholines

Browse Leaves

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Browse Branches

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