Management of Antiplatelet Regimen During Surgical Procedures (MARS)

December 5, 2023 updated by: Subhash Banerjee, Baylor Research Institute

Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)

There are key differences today in clinical practice regarding perioperative management of post-PCI patients on DAPT undergoing NCS. Moreover, there are significant differences between bridging agents, and improved safety of current-generation DES. Given the significant limitations of current studies a well-designed registry to study current U.S. practice patterns and the bleeding or ischemic risks associated with the various perioperative DAPT management strategies including bridging and no bridging will significantly add to the understanding of the current problem and associated risks of patients. These data could form the basis for conducting future randomized clinical trials (RCTs) in this area. NCS in post-PCI patients on chronic DAPT presents a complex interaction of both ischemic and bleeding risks.

The MARS registry will study the area of perioperative antiplatelet therapy management through a multicenter observational national registry designed to collect pre-operative, intra-operative and post-operative clinical strategies, therapeutic interventions and outcomes data. This proposal outlines the role of a highly experienced clinical trial team to conduct a multicenter prospective registry. This question is highly relevant to a diverse group of medical providers and millions of patients in the US and around the world; this will be the first such U.S. registry to address this critically important public health issue.

Study objectives:

i. To collect data on contemporary clinical practice in the U.S. on managing post percutaneous coronary intervention (PCI) DAPT in patients scheduled to undergo NCS and CS.

ii. To assess ischemic and bleeding endpoints in this group of patients during the study period.

iii. To generate initial data to plan for future large-scale randomized clinical trials on perioperative management of DAPT.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. Registry infrastructure: The proposed registry is a multicenter prospective registry that is designed to capture perioperative DAPT management strategies in patients undergoing NCS or CS post-PCI. It will be adjudicated and monitored for data accuracy and completeness. The registry will be de-identified and compliant with HIPPA regulations and will be located on secure servers of the University of Texas Southwestern Medical Center (UTSW). Full-time staff that includes an information technology officer and data programmer manages the registry servers professionally. The servers are backed up daily and provide on-line secure access to site investigators and coordinators. The current registry structure is already in use for a national peripheral artery disease registry and can be viewed at www.XLPAD.org. The MARS registry will include two separate registry arms to capture data on two distinct cohorts: (i) NCS and (ii) CS.
  2. Hypothesis: This observational registry is designed to test whether 30-day NACE associated with IV APT bridging is ≥6%.
  3. Study period: period of 14 days prior to surgery to 30 days post-surgery.

  4. Study eligible NCS or CS :

    • Study eligible non-cardiac surgeries and procedures:

      1. Intra-abdominal surgery (e.g., bowel or visceral organ resection) *
      2. Intra-thoracic surgery (e.g., lung resection) *
      3. Major orthopedic surgery (e.g., hip or knee replacement)
      4. Peripheral arterial revascularization (e.g., aortic aneurysm repair*, vascular bypass*, carotid surgery)
      5. Urologic surgery (e.g., prostatectomy*, bladder tumor resection);
      6. Major procedure (e.g., renal, lung or liver transplants*, biopsy of lung, head and neck surgery*)
      7. Breast and other surgeries or procedures requiring DAPT interruption as per the clinical team *High-risk NCS, remaining classified as low-intermediate

    • Study eligible cardiac surgeries and procedures

      1. Coronary artery bypass graft (CABG)
      2. Cardiac valve repair or replacement with or without CABG
      3. Surgical arrhythmia treatment (MAZE procedure)
      4. Pericardial procedures
      5. Thoracoscopic procedures
      6. Other cardiothoracic procedures (please contact study tem)
  5. Study population: Post-PCI patients on DAPT undergoing NCS and CS. Patients will be asked to sign an informed consent form (ICF) or ICF deferred based on the mandate of their respective institutional review boards (IRB).
  6. Registry data collection: The registry will be built on the NHLBI's REDCap data collection portal that is available to UTSW under an Academic Information Systems NIH grant UL1-RR024982. The proposed MARS Registry data collection portal. The data collection portal has been designed to facilitate comprehensive data collection from 2 weeks prior to surgery to 30±7 days post-surgery and includes demographics, laboratory, coronary revascularization, medication and clinical outcome information. Baseline information will include demographic, relevant medical history, preoperative medications and laboratory values and any preoperative clinical events during the study period. Procedure related data will include surgical procedure details, intraoperative medications and medications, laboratory values and clinical outcomes from the day of surgery till hospital discharge. Postoperative data collection will include medications, laboratory values and clinical events between hospital discharge and 30 days post-discharge. Data will be entered into a secure and HIPPA compliant online REDCap data collection portal. No study related procedures, interventions or follow-ups are required. Each site staff will enter data based on electronic health records (EHR), which wills serve as the primary data source. Out of hospital medical records will need to be incorporated or documented as part of a given participants' source data. All participants will be given the opportunity to re-evaluate their decisions regarding participation in the MARS Registry. The MARS registry will include two separate arms of the registry to capture data on two distinct cohorts: (i) NCS and (ii) CS.

Study Type

Observational

Enrollment (Estimated)

1492

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
    • Florida
      • Jacksonville, Florida, United States, 32209
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Dominick J Angiolillo, MD
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390
        • Completed
        • UT Southwestern Medical Center
      • Dallas, Texas, United States, 75226
        • Recruiting
        • Baylor Scott & White Research Institute
        • Principal Investigator:
          • Subhash Banerjee, MD
        • Contact:
      • Dallas, Texas, United States, 75216
        • Completed
        • Dallas VA Medical Center
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Completed
        • Mary Washington Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Post-PCI patients on DAPT undergoing NCS and CS. Patients will be asked to sign an informed consent form (ICF) based on the mandate of their respective institutional review boards (IRB).

Description

Inclusion Criteria:

  • Patients with PCI within the past 2 years who: a. Are currently on DAPT, OR b. Have a current indication for DAPT
  • Scheduled for NCS or CS.
  • Willing and able to provide an informed consent (if needed based on institutional IRB requirements).

Exclusion Criteria:

  • Emergent (6 hours) surgery post-PCI on DAPT that precludes a thorough informed consent process.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Post -PCI Patients scheduled for Cardiac Surgery
Post -PCI Patients (PCI within the last 2 years) who are currently on Dual- Antiplatelet (DAPT) Medication or have a current indication for DAPT, who will be undergoing Cardiac Surgery. No intervention will be administered.
Post -PCI Patients scheduled for Non- Cardiac Surgery
Post -PCI Patients (PCI within the last 2 years) who are currently on Dual- Antiplatelet (DAPT) Medication or have a current indication for DAPT, who will be undergoing Non-Cardiac Surgery. No intervention will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Net adverse cardiovascular events (NACE) over the study period
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
A composite of cardiovascular (CV) death, non-fatal myocardial infarction (MI), ischemic stroke, need for urgent coronary revascularization (UCR) or Bleeding Academic Research Consortium (BARC) ≥3 bleeding during the study period.
2 weeks prior to surgery to up to 30 days post-surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of individual components of NACE over the study period
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
Incidence of cardiovascular (CV) death, non-fatal myocardial infarction (MI), ischemic stroke, need for urgent coronary revascularization (UCR) or Bleeding Academic Research Consortium (BARC) ≥3 bleeding during the study period.
2 weeks prior to surgery to up to 30 days post-surgery
Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.
2 weeks prior to surgery to up to 30 days post-surgery
Time to NACE
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
Time to NACE
2 weeks prior to surgery to up to 30 days post-surgery
All-cause mortality
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
All-cause mortality
2 weeks prior to surgery to up to 30 days post-surgery
Incidence of definite and probable stent thrombosis (ST).
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
Incidence of definite and probable stent thrombosis (ST).
2 weeks prior to surgery to up to 30 days post-surgery
Length of hospital stay (LOS).
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
Length of hospital stay (LOS).
2 weeks prior to surgery to up to 30 days post-surgery
Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.
Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery
Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.
2 weeks prior to surgery to up to 30 days post-surgery

Collaborators and Investigators

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

Sponsor

Baylor Research Institute

Collaborators

Chiesi USA, Inc.

Investigators

  • Study Chair: Subhash Banerjee, MD, Baylor Scott & White Research Institute

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)

August 1, 2019

Primary Completion (Estimated)

March 19, 2025

Study Completion (Estimated)

March 19, 2025

Study Registration Dates

First Submitted

June 6, 2019

First Submitted That Met QC Criteria

June 6, 2019

First Posted (Actual)

June 11, 2019

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 5, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • STU-2018-0398

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

No

Studies a U.S. FDA-regulated device product

No

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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