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Cardiac SurgeryMARSNCT03981835

Management of Antiplatelet Regimen During Surgical Procedures

An observational study of Cardiac Surgery and Surgery, run by Baylor Research Institute at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
147 participants
Where
5 sitesUnited States
Study dates
1 Aug 2019to 30 Jan 2024
How long will I take part?
30 Days
Phase
Observational
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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).

Who cannot join

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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Dallas VA Medical Center

    Dallas, Texas, 75216

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75226

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • Mary Washington Hospital

    Fredericksburg, Virginia, 22401

  • University of Florida

    Jacksonville, Florida, 32209

Other trials in United States

About this study

Official title: 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.

Read more

Study objectives:

  1. 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.
Read the 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)
  7. 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).
  8. 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.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03981835
Study groupRoleWhat they receive
Post -PCI Patients scheduled for Cardiac SurgeryPost -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 SurgeryPost -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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Net adverse cardiovascular events (NACE) over the study period

    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.

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

Secondary outcomes (7)

  1. Incidence of individual components of NACE over the study period

    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.

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

  2. Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.

    Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

  3. Time to NACE

    Time to NACE

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

  4. All-cause mortality

    All-cause mortality

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

  5. Incidence of definite and probable stent thrombosis (ST).

    Incidence of definite and probable stent thrombosis (ST).

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

  6. Length of hospital stay (LOS).

    Length of hospital stay (LOS).

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

  7. Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.

    Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.

    Measured: 2 weeks prior to surgery to up to 30 days post-surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2019
  2. Study start1 Aug 2019
  3. Primary completion30 Jan 2024
  4. Study completion30 Jan 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
147 participants (actual)
Target duration
30 Days
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981835
Sponsor's protocol ID
STU-2018-0398
Acronym
MARS
Status last verified
Dec 2023
First submitted
6 Jun 2019
Last updated
6 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Auerbach DI, Maeda JL, Steiner C. Hospital Stays with Cardiac Stents, 2009. 2012 Apr. In: Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Statistical Brief #128. Available from http://www.ncbi.nlm.nih.gov/books/NBK97358/

    PubMed 22696778

  • Bangalore S, Gupta N, Guo Y, Feit F. Trend in the use of drug eluting stents in the United States: insight from over 8.1 million coronary interventions. Int J Cardiol. 2014 Jul 15;175(1):108-19. doi: 10.1016/j.ijcard.2014.04.269. Epub 2014 May 9.

    PubMed 24852837

  • Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; ACCF; AHA; SCAI. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: executive summary: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Catheter Cardiovasc Interv. 2012 Feb 15;79(3):453-95. doi: 10.1002/ccd.23438. No abstract available.

    PubMed 22328235

  • Capodanno D, Angiolillo DJ. Management of antiplatelet therapy in patients with coronary artery disease requiring cardiac and noncardiac surgery. Circulation. 2013 Dec 24;128(25):2785-98. doi: 10.1161/CIRCULATIONAHA.113.003675. No abstract available.

    PubMed 24366588

  • Bonaca MP, Braunwald E, Sabatine MS. Long-Term Use of Ticagrelor in Patients with Prior Myocardial Infarction. N Engl J Med. 2015 Sep 24;373(13):1274-5. doi: 10.1056/NEJMc1508692. No abstract available.

    PubMed 26398078

  • Alshawabkeh LI, Prasad A, Lenkovsky F, Makary LF, Kandil ES, Weideman RA, Kelly KC, Rangan BV, Banerjee S, Brilakis ES. Outcomes of a preoperative "bridging" strategy with glycoprotein IIb/IIIa inhibitors to prevent perioperative stent thrombosis in patients with drug-eluting stents who undergo surgery necessitating interruption of thienopyridine administration. EuroIntervention. 2013 Jun 22;9(2):204-11. doi: 10.4244/EIJV9I2A35.

    PubMed 23454910

  • Habib A, Finn AV. Endothelialization of drug eluting stents and its impact on dual anti-platelet therapy duration. Pharmacol Res. 2015 Mar;93:22-7. doi: 10.1016/j.phrs.2014.12.003. Epub 2014 Dec 19.

    PubMed 25533811

  • McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9.

    PubMed 15500897

  • Ong AT, Hoye A, Aoki J, van Mieghem CA, Rodriguez Granillo GA, Sonnenschein K, Regar E, McFadden EP, Sianos G, van der Giessen WJ, de Jaegere PP, de Feyter P, van Domburg RT, Serruys PW. Thirty-day incidence and six-month clinical outcome of thrombotic stent occlusion after bare-metal, sirolimus, or paclitaxel stent implantation. J Am Coll Cardiol. 2005 Mar 15;45(6):947-53. doi: 10.1016/j.jacc.2004.09.079.

    PubMed 15766834

  • Regar E, Lemos PA, Saia F, Degertekin M, Tanabe K, Lee CH, Arampatzis CA, Hoye A, Sianos G, de Feyter P, van der Giessen WJ, Smits PC, van Domburg RT, Serruys PW. Incidence of thrombotic stent occlusion during the first three months after sirolimus-eluting stent implantation in 500 consecutive patients. Am J Cardiol. 2004 May 15;93(10):1271-5. doi: 10.1016/j.amjcard.2004.02.013.

    PubMed 15135702

  • Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005 May 4;293(17):2126-30. doi: 10.1001/jama.293.17.2126.

    PubMed 15870416

  • Rossini R, Musumeci G, Capodanno D, Lettieri C, Limbruno U, Tarantini G, Russo N, Calabria P, Romano M, Inashvili A, Sirbu V, Guagliumi G, Valsecchi O, Senni M, Gavazzi A, Angiolillo DJ. Perioperative management of oral antiplatelet therapy and clinical outcomes in coronary stent patients undergoing surgery. Results of a multicentre registry. Thromb Haemost. 2015 Feb;113(2):272-82. doi: 10.1160/TH14-05-0436. Epub 2014 Oct 2.

    PubMed 25274620

  • Silber S, Kirtane AJ, Belardi JA, Liu M, Brar S, Rothman M, Windecker S. Lack of association between dual antiplatelet therapy use and stent thrombosis between 1 and 12 months following resolute zotarolimus-eluting stent implantation. Eur Heart J. 2014 Aug 1;35(29):1949-56. doi: 10.1093/eurheartj/ehu026. Epub 2014 Feb 7.

    PubMed 24510638

  • Fleisher LA, Fleischmann KE, Auerbach AD, Barnason SA, Beckman JA, Bozkurt B, Davila-Roman VG, Gerhard-Herman MD, Holly TA, Kane GC, Marine JE, Nelson MT, Spencer CC, Thompson A, Ting HH, Uretsky BF, Wijeysundera DN. 2014 ACC/AHA guideline on perioperative cardiovascular evaluation and management of patients undergoing noncardiac surgery: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines. Developed in collaboration with the American College of Surgeons, American Society of Anesthesiologists, American Society of Echocardiography, American Society of Nuclear Cardiology, Heart Rhythm Society, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Anesthesiologists, and Society of Vascular Medicine Endorsed by the Society of Hospital Medicine. J Nucl Cardiol. 2015 Feb;22(1):162-215. doi: 10.1007/s12350-014-0025-z. No abstract available.

    PubMed 25523415

  • Hawn MT, Graham LA, Richman JS, Itani KM, Henderson WG, Maddox TM. Risk of major adverse cardiac events following noncardiac surgery in patients with coronary stents. JAMA. 2013 Oct 9;310(14):1462-72. doi: 10.1001/jama.2013.278787.

    PubMed 24101118

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Surgery and Surgery, run by Baylor Research Institute at 5 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03981835, which also lists 43 linked publications.

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 Feb 2026.

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