Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)

June 3, 2026 updated by: Duke University

Evaluation of Inclisiran Versus Placebo for the Prevention of Major Adverse Cardiovascular and Limb Events in Patients Undergoing Percutaneous Coronary Intervention or Peripheral Endovascular Intervention (V-INTERVENTION)

V-INTERVENTION will evaluate the effectiveness of inclisiran in preventing major cardiovascular and limb events in patients receiving percutaneous coronary or peripheral arterial revascularization. Inclisiran is a subcutaneous, twice-yearly injection that is FDA-approved as an adjunct with statin therapy and on the market to lower LDL-C in high-risk populations.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CKJX839D1US04R is a pragmatic, randomized, double-blind, parallel group, placebo-controlled, multicenter, event-driven study evaluating inclisiran sodium 300 mg subcutaneous administered on Day 1, Month 3 (Day 90), and every 6 months thereafter in participants presenting for elective or urgent percutaneous coronary or peripheral endovascular intervention (PCI or PVI). At the time of a successful revascularization procedure or up to 14 days following the procedure, participants will be randomized and administered the first dose of inclisiran or corresponding placebo in a 1:1 fashion, stratified by the type of index arterial revascularization procedure, either coronary (i.e., PCI) or lower extremity (i.e., PV).

The enrollment population will be representative of typical patients in the US with atherosclerotic cardiovascular disease, either coronary artery disease (CAD) or peripheral artery disease (PAD), and the trial endpoints are designed to be scientifically relevant and clinically meaningful to patients, clinicians, and other persons involved in the care of cardiovascular patients. The trial is designed to also understand how inclisiran therapy can be implemented in real-world clinical practice settings.

The expected enrollment of the trial is approximately 6,000 participants, randomized in a 1:1 fashion to receive inclisiran or placebo, within 14 days of successful percutaneous coronary or lower extremity peripheral endovascular intervention for symptomatic atherosclerotic cardiovascular disease (ASCVD).

Inclisiran sodium or corresponding placebo will be administered by s.c. injection to participants presenting for percutaneous coronary or peripheral endovascular intervention, in addition to usual care according to their individual medical history. All participants randomized to the treatment arm will receive inclisiran in addition to usual care per their regular physician direction, and those participants randomized to placebo will receive matching placebo, as well as usual care treatment, according to their treating physician.

Study duration is determined by event accrual consistent with the event-driven design, i.e., when approximately 2380 primary composite events have occurred and at least 50% of participants have at least 36 months of follow-up. Assuming 18 months of recruitment at a uniform rate, the last patients enrolled will have about 27 months of follow-up. Therefore, study duration should be approximately 4 years.

The study is event-driven, and thus, all participants will be treated (or followed in the case of permanent discontinuation of study drug) until the End of Study visit. As such, the planned duration of treatment cannot be stipulated for an individual participant. The estimated maximum treatment period for an individual participant is approximately 45 months, and the mean treatment duration is expected to be approximately 36 months.

Study Type

Interventional

Enrollment (Estimated)

6000

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Alexander City, Alabama, United States, 35010
        • Recruiting
        • Advanced Cardiovascular LLC
        • Contact:
        • Principal Investigator:
          • Brian Foley, MD
      • Birmingham, Alabama, United States, 35211
        • Recruiting
        • Cardiology, PC
        • Contact:
        • Principal Investigator:
          • Hutton Brantley, MD
      • Huntsville, Alabama, United States, 35801
        • Recruiting
        • Heart Center Research, LLC
        • Contact:
        • Principal Investigator:
          • Henry Chen, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Arkansas Cardiology
        • Principal Investigator:
          • David Jones, MD
        • Contact:
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Pacific Oaks Medical Group
        • Principal Investigator:
          • Ramprasad Dandillaya, MD
        • Contact:
      • Covina, California, United States, 91723
        • Withdrawn
        • Valley Clinical Trials
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Radin Cardiovascular Medical Group, Inc
        • Principal Investigator:
          • Michael Radin, MD
        • Contact:
      • Northridge, California, United States, 91325
        • Recruiting
        • Valley Clinical Trials, LLC - Flourish Research
        • Principal Investigator:
          • Mehrdad Ariani, MD
        • Contact:
      • Riverside, California, United States, 92501
        • Recruiting
        • Riverside Community Hospital
        • Principal Investigator:
          • Patrick Hu, MD
        • Contact:
      • San Diego, California, United States, 92123
        • Recruiting
        • San Diego Cardiac Center
        • Contact:
        • Principal Investigator:
          • Jiken Bhatt, MD
      • Torrance, California, United States, 90502
        • Recruiting
        • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Quang Bui, MD
      • Van Nuys, California, United States, 91406
        • Recruiting
        • The Heart Medical Group
        • Contact:
        • Principal Investigator:
          • Munaf Shamji, MD
      • Ventura, California, United States, 93030
        • Recruiting
        • FOMAT - West Coast Research Center
        • Principal Investigator:
          • David Blitzer, MD
        • Contact:
      • West Hills, California, United States, 91307
        • Recruiting
        • Interventional Cardiology Medical Group
        • Principal Investigator:
          • Farhad Rafii, MD
        • Contact:
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Recruiting
        • Nuvance Health- Danbury Hospital
        • Principal Investigator:
          • Hal Wasserman, MD
        • Contact:
      • Stamford, Connecticut, United States, 06305
        • Recruiting
        • Cardiology Associates of Fairfield County
        • Contact:
        • Contact:
        • Principal Investigator:
          • Edward Portnay, MD
    • Florida
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Clearwater Cardiovascular Consultants
        • Contact:
        • Principal Investigator:
          • Masood Gilani, MD
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • BayCare Medical Group
        • Contact:
        • Principal Investigator:
          • Rakesh Sharma, MD
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Pioneer Clinical Studies
        • Contact:
        • Principal Investigator:
          • Vinod Chainani, MD
      • Daytona Beach, Florida, United States, 32117
        • Recruiting
        • Arrow Clinical Trails
        • Principal Investigator:
          • Charles Ross, MD
        • Contact:
      • Largo, Florida, United States, 33777
        • Recruiting
        • Clearwater Cardiovascular and Interventional Consultants- Bardmoor
        • Contact:
        • Principal Investigator:
          • Alexander Heckman, MD
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Inpatient Research Clinic, LLC
        • Contact:
        • Principal Investigator:
          • Francisco Dieguez Jr, MD
      • Panama City, Florida, United States, 32405
        • Recruiting
        • Cardiovascular Institute of Northwest Florida
        • Principal Investigator:
          • Amir Haghighat, MD
        • Contact:
      • Port Charlotte, Florida, United States, 33948
        • Recruiting
        • Charlotte Heart & Vascular Center, PA
        • Contact:
        • Principal Investigator:
          • Mario Lopez, MD
      • Safety Harbor, Florida, United States, 34695
        • Recruiting
        • Clearwater Cardiovascular Consultants
        • Contact:
        • Principal Investigator:
          • Paul Phillips, MD
      • Tampa, Florida, United States, 33614
        • Recruiting
        • Tampa Cardiovascular Interventions and Research
        • Principal Investigator:
          • Saihari Sadanandan, MD
        • Contact:
    • Georgia
      • Gainesville, Georgia, United States, 30501
        • Recruiting
        • Northeast Georgia Heart Center, PC
        • Contact:
        • Principal Investigator:
          • Nima Ghasemzadeh, MD
      • Peachtree City, Georgia, United States, 30269
      • Tucker, Georgia, United States, 30084
        • Recruiting
        • Atlanta Heart Specialists LLC
        • Contact:
        • Principal Investigator:
          • David Suh, MD
    • Indiana
      • Elkhart, Indiana, United States, 46514
        • Recruiting
        • Midwest Cardiovascular Research and Education Foundation
        • Principal Investigator:
          • Troy Weirick, MD
        • Contact:
      • Richmond, Indiana, United States, 47374
        • Recruiting
        • Reid Physician Associates
        • Contact:
        • Principal Investigator:
          • John McGinty, MD
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Recruiting
        • Iowa Heart Center
        • Contact:
        • Principal Investigator:
          • Jose Borromeo, MD
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Recruiting
        • Midwest Heart and Vascular Specialists
        • Principal Investigator:
          • Stephen Bloom, MD
        • Contact:
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Recruiting
        • Research Integrity, LLC
        • Contact:
        • Principal Investigator:
          • Kishor Vora, MD
    • Louisiana
      • Bossier City, Louisiana, United States, 71111
        • Recruiting
        • Grace Research, LLC
        • Contact:
        • Principal Investigator:
          • William Eaves, MD
      • Covington, Louisiana, United States, 70433
        • Recruiting
        • LOUISIANA HEART Center
        • Contact:
        • Principal Investigator:
          • Bruce Iteld, MD
      • New Orleans, Louisiana, United States, 70112
        • Recruiting
        • Tulane School of Medicine
        • Principal Investigator:
          • Anand Irimpen, MD
        • Contact:
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Cardiovascular Solutions, LLC
        • Contact:
        • Principal Investigator:
          • Wenwu Zhang, MD
      • West Monroe, Louisiana, United States, 71291
    • Maine
      • Bangor, Maine, United States, 04401
        • Recruiting
        • Northern Light Eastern Maine Medical Center
        • Contact:
        • Principal Investigator:
          • Alan Wiseman, MD
    • Maryland
      • Lanham, Maryland, United States, 20706
        • Recruiting
        • Capitol Cardiology Associates PA
        • Contact:
        • Principal Investigator:
          • Vivek Bahl, MD
      • Rockville, Maryland, United States, 20850
        • Recruiting
        • Shady Grove Adventist Hospital
        • Contact:
        • Principal Investigator:
          • Bryan White, MD
      • Salisbury, Maryland, United States, 21804
        • Recruiting
        • TidalHealth Peninsula Regional
        • Principal Investigator:
          • Steven Hearne, MD
        • Contact:
      • Silver Spring, Maryland, United States, 20904
        • Recruiting
        • Jadestone Clinical Research, LLC
        • Contact:
        • Principal Investigator:
          • Homan Ibrahim, MD
    • Michigan
      • Lansing, Michigan, United States, 48912
        • Recruiting
        • UMH-Sparrow Clinical Research Institute
        • Contact:
        • Principal Investigator:
          • Chad Link, MD
      • Midland, Michigan, United States, 48670
        • Recruiting
        • MyMichigan Medical Center Midland
        • Contact:
        • Principal Investigator:
          • William Felten, MD
      • Rochester Hills, Michigan, United States, 48307
        • Recruiting
        • Healthy Heart Cardiology at Rochester Hills (Advanced Cardiology Associates
        • Contact:
        • Principal Investigator:
          • Sandeep Khurana, MD
    • Minnesota
      • Duluth, Minnesota, United States, 55805
        • Recruiting
        • Aspirus Saint Luke's Hospital
        • Contact:
        • Principal Investigator:
          • Scott Mikesell, MD
      • Mankato, Minnesota, United States, 56001
        • Recruiting
        • JAVARA Inc, - Mankato Clinic
        • Contact:
        • Principal Investigator:
          • Manpreet Kanwar, MD
    • Mississippi
      • Southaven, Mississippi, United States, 38671
        • Recruiting
        • Stern Cardiovascular
        • Principal Investigator:
          • Dharmesh Patel, MD
        • Contact:
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • Cardiology Associates of North Mississippi
        • Contact:
        • Principal Investigator:
          • Richard Ballard, MD
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • CHI Health Nebraska Heart
        • Contact:
        • Principal Investigator:
          • Douglas Kosmicki, MD
      • Lincoln, Nebraska, United States, 68526
        • Recruiting
        • CHI Health Nebraska Heart
        • Contact:
        • Principal Investigator:
          • Anuradha Tunuguntla, MD
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Bryan Heart
        • Contact:
        • Principal Investigator:
          • Rajeev Anchan, MD
      • Omaha, Nebraska, United States, 68114
        • Recruiting
        • Methodist Physicians Clinic Heart Consultants
        • Contact:
        • Principal Investigator:
          • William Nester, MD
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth-Hitchcock Medical Center
        • Contact:
        • Principal Investigator:
          • Jocelyn Beach, MD
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Recruiting
        • Advanced Heart Care LLC
        • Principal Investigator:
          • Sharan Mahal, MD
        • Contact:
      • Elmer, New Jersey, United States, 08318
        • Recruiting
        • Cardiovascular Associates of the Delaware Valley
        • Contact:
        • Principal Investigator:
          • Mark Gelernt, MD
      • Flemington, New Jersey, United States, 08822
        • Recruiting
        • Advanced Heart and Vascular Institute of Hunterdon
        • Principal Investigator:
          • Andrey Espinoza, MD
        • Contact:
      • Haddon Heights, New Jersey, United States, 08035
        • Recruiting
        • Cardiovascular Associates of the Delaware Valley
        • Contact:
        • Principal Investigator:
          • Sanford Gips, MD
      • Pomona, New Jersey, United States, 08240
        • Recruiting
        • Atlanticare Regional Medical Center
        • Contact:
        • Principal Investigator:
          • Sanjay Shetty, MD
      • Sewell, New Jersey, United States, 08080
        • Recruiting
        • Cardiovascular Associates of the Delaware Valley
        • Contact:
        • Principal Investigator:
          • Dilip Viswanath, MD
    • New York
      • Albany, New York, United States, 12211
        • Recruiting
        • Capital Cardiology Associates
        • Contact:
        • Principal Investigator:
          • Krzysztof Drzymalski, MD
      • Buffalo, New York, United States, 14214
        • Recruiting
        • Sisters of Charity Hospital
        • Principal Investigator:
          • Paul Anain, MD
        • Contact:
      • Buffalo, New York, United States, 14214
        • Recruiting
        • Trinity Medical WNY, PC
        • Contact:
        • Principal Investigator:
          • Henry Meltser, MD
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai School of Medicine
        • Principal Investigator:
          • Prakash Krishnan, MD
        • Contact:
      • Poughkeepsie, New York, United States, 12601
        • Recruiting
        • Hudson Valley Cardiovascular Practice PC
        • Contact:
        • Principal Investigator:
          • Sunny Intwala, MD
      • Staten Island, New York, United States, 10310
        • Recruiting
        • Richmond University Medical Center
        • Principal Investigator:
          • Francesco Rotatori, MD
        • Contact:
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Asheville Cardiology Associates Research Department
        • Contact:
        • Principal Investigator:
          • William Pomeroy, MD
      • Charlotte, North Carolina, United States, 28207
        • Recruiting
        • Mecklenburg Heart Specialists
        • Contact:
        • Principal Investigator:
          • Aamer Qureshi, MD
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Clinical Research/Heart & Vascular Institute
        • Contact:
        • Principal Investigator:
          • Daniel Pu, MD
      • Fayetteville, North Carolina, United States, 28304
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Duke Cardiology
        • Principal Investigator:
          • Schuyler Jones, MD
        • Contact:
    • Ohio
      • Canton, Ohio, United States, 44710
        • Recruiting
        • Aultman Hospital
        • Contact:
        • Principal Investigator:
          • Ramana Podugu, MD
      • Springfield, Ohio, United States, 45505
        • Recruiting
        • Heart House Research Foundation LLC
        • Contact:
        • Principal Investigator:
          • Mian Bilal Alam, MD
      • Zanesville, Ohio, United States, 43701
        • Recruiting
        • Genesis HealthCare System
        • Contact:
        • Principal Investigator:
          • Abdulhay Albirini, MD
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73135
        • Recruiting
        • South Oklahoma Heart Research, LLC
        • Principal Investigator:
          • Naeem Tahirkheli, MD
        • Contact:
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • Capital Area Research LLC
        • Principal Investigator:
          • Venkatesh Nadar, MD
        • Contact:
      • Chambersburg, Pennsylvania, United States, 17201
        • Recruiting
        • Wellspan Chambersburg Hospital
        • Contact:
        • Principal Investigator:
          • Aylmer Tang, MD
      • West Reading, Pennsylvania, United States, 19611
        • Recruiting
        • Cardiology Associates of West Reading
        • Contact:
        • Principal Investigator:
          • Earl Hope, MD
      • York, Pennsylvania, United States, 17403
        • Recruiting
        • WellSpan Heart and Vascular Research
        • Principal Investigator:
          • Rhian Davies, MD
        • Contact:
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • AnMed Health Medical Center
        • Contact:
        • Principal Investigator:
          • John Meehan, MD
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Stern Cardiovascular Center
        • Contact:
        • Principal Investigator:
          • Tamunoinemi Bob-Manuel, MD
      • Jackson, Tennessee, United States, 38301
        • Recruiting
        • Apex Research Foundation, LLC
        • Principal Investigator:
          • Mohsin Alhaddad, MD
        • Contact:
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • TriStar Centennial Medical center
        • Contact:
        • Principal Investigator:
          • David Huneycutt, MD
    • Texas
      • Amarillo, Texas, United States, 79106
        • Recruiting
        • PharmaTex Research
        • Principal Investigator:
          • David Brabham, DO
        • Contact:
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Amarillo Heart Clinical Research Institute, Inc.
        • Contact:
        • Principal Investigator:
          • Joaquin Martinez-Arraras, MD
      • Austin, Texas, United States, 78705
        • Recruiting
        • Austin Heart
        • Principal Investigator:
          • Frank Zidar, MD
        • Contact:
      • Conroe, Texas, United States, 77384
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Texas Cardiology Associates of Houston
        • Contact:
        • Principal Investigator:
          • Ira Lieber, MD
      • Lufkin, Texas, United States, 75904
        • Recruiting
        • Heart Institute of East Texas
        • Contact:
        • Principal Investigator:
          • Ravinder Bachireddy, MD
      • Round Rock, Texas, United States, 78681
        • Recruiting
        • Austin Heart PLLC
        • Contact:
        • Principal Investigator:
          • Joseph Szczytowski, MD
      • San Marcos, Texas, United States, 78666
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Northwest Houston Heart Center
        • Principal Investigator:
          • Shamaila Aslam, MD
        • Contact:
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Viva Heart and Vein
        • Contact:
        • Principal Investigator:
          • Taher Mandviwala, MD
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Recruiting
        • TPMG Clinical Research
        • Contact:
        • Principal Investigator:
          • Linda Schneider, MD
      • Richmond, Virginia, United States, 23225
    • Washington
      • Puyallup, Washington, United States, 98372
        • Recruiting
        • MultiCare Institute for Research and Innovation
        • Contact:
        • Principal Investigator:
          • Ahmad Slim, MD
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Institute for Research and Innovation
        • Contact:
        • Principal Investigator:
          • Daniel Guerra, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent must be obtained prior to participation in the study.
  • Males or females ≥ 18 years of age
  • Within 14 days of a successful percutaneous coronary intervention (PCI) or peripheral endovascular intervention (PVI) for symptomatic CAD or lower extremity PAD
  • Patients undergoing planned staged interventions are eligible for randomization only after the last planned intervention

Exclusion Criteria:

  • Planned future PCI or PVI
  • Current or planned use of an open-label PCSK9 inhibitor during the study
  • Any prior treatment with inclisiran
  • Active or planned participation in another clinical study involving investigational drugs or devices during the study
  • Any serious liver disease, metabolic disease, neoplasm, end-stage kidney disease, or other condition in the opinion of the investigator that would inhibit trial participation or confound trial results
  • Any other reason why, in the opinion of the investigator, the participant would not be suitable for study participation including safety considerations and the ability to adhere to protocol activities
  • Patients taking prohibited therapies as listed in Section 6.6.3
  • Pregnant or breast-feeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Inclisiran Sodium
Inclisiran sodium 300 mg subcutaneous injection
Drug: Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
300 mg (equivalent to 284 mg inclisiran) in 1.5 mL subcutaneous injection at Day 0; Day 90; & every 6 months thereafter
Placebo Comparator: Placebo
Normal saline 1.5 ml subcutaneous injection
Drug: Normal Saline (Placebo)
Normal saline placebo subcutaneous injection given at Day 0, Day 90; & every 6 months thereafter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total number of major adverse cardiovascular events (MACE) after coronary or peripheral endovascular revascularization
Time Frame: From randomization to first occurrence of MACE (up to approximately 4 years)
MACEs include CHD death, non-fatal MI, ischemic stroke, ALI, major (above the ankle) amputation of vascular etiology, clinically driven coronary and limb revascularization.
From randomization to first occurrence of MACE (up to approximately 4 years)
Total number of major adverse limb events (MALE) after endovascular revascularization
Time Frame: From randomization to first occurrence of MALE (up to approximately 4 years)
MALEs consist of ALI, major amputation of vascular etiology, clinically driven lower extremity peripheral revascularization.
From randomization to first occurrence of MALE (up to approximately 4 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with cardiovascular (CV) death
Time Frame: From randomization to CV death (up to approximately 4 years)
From randomization to CV death (up to approximately 4 years)
Number of participants with all cause death
Time Frame: From randomization to all cause death (up to approximately 4 years)
From randomization to all cause death (up to approximately 4 years)
Number of participants with venous thromboembolic events (VTE)
Time Frame: From randomization to first VTE (up to approximately 4 years)
From randomization to first VTE (up to approximately 4 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Novartis Pharmaceuticals
Mount Sinai Hospital, New York
Colorado Prevention Center

Investigators

  • Study Chair: Manesh Patel, MD, Duke University
  • Principal Investigator: Schuyler Jones, MD, Duke Clinical Research Institute
  • Principal Investigator: Marc Bonaca, MD, Colorado Prevention Center
  • Study Chair: Roxana Mehran, MD, Mt Sinai

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 23, 2025

Primary Completion (Estimated)

October 1, 2029

Study Completion (Estimated)

December 1, 2029

Study Registration Dates

First Submitted

March 27, 2025

First Submitted That Met QC Criteria

March 27, 2025

First Posted (Actual)

April 3, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00116826
  • CKJX839D1US04R (Other Identifier: Novartis Pharmaceuticals Corporation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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