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Management of Antiplatelet Regimen During Surgical Procedures (MARS)

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ClinicalTrials.gov Identifier: NCT03981835
Recruitment Status : Recruiting
First Posted : June 11, 2019
Last Update Posted : October 2, 2019
Sponsor:
Collaborator:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center

Brief 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. 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.


Condition or disease
Cardiac Surgery Surgery Percutaneous Coronary Intervention Surgery--Complications

  Show Detailed Description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1492 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 30 Days
Official Title: Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)
Actual Study Start Date : August 1, 2019
Estimated Primary Completion Date : March 19, 2025
Estimated Study Completion Date : March 19, 2025

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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. 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.

  3. Time to NACE [ Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery ]
    Time to NACE

  4. All-cause mortality [ Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery ]
    All-cause mortality

  5. 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).

  6. Length of hospital stay (LOS). [ Time Frame: 2 weeks prior to surgery to up to 30 days post-surgery ]
    Length of hospital stay (LOS).

  7. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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).
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03981835


Contacts
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Contact: Subhash Banerjee, MD 214-857-1608 subhash.banerjee@utsouthwestern.edu
Contact: Ishita Y Tejani, BDS,MS,CCRP 2148573048 Ishita.Tejani@UTSouthwestern.edu

Locations
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United States, Texas
Dallas VA Medical Center Not yet recruiting
Dallas, Texas, United States, 75216
Contact: Amutha Baskar, MBBS, CCRP    214-857-0305    amutharani.baskar@va.gov   
Principal Investigator: Nicole Minniefield, MD         
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Ishita Y Tejani, BDS,MS,CCRP    214-857-3048    ishita.tejani@utsouthwestern.edu   
Principal Investigator: Hurst Hall, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Chiesi Farmaceutici S.p.A.
Investigators
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Study Chair: Subhash Banerjee, MD UT Southwestern Medical Center

Publications:
Auerbach D, Maeda J, Steiner C. Hospital Stays with Cardiac Stents, 2009. HCUP Statistical Brief #128. Agency for Healthcare Research and Quality, Rockville, MD. April 2012.
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.
Rossini R, Musumeci G, Visconti LO, Bramucci E, Castiglioni B, De Servi S, Lettieri C, Lettino M, Piccaluga E, Savonitto S, Trabattoni D, Capodanno D, Buffoli F, Parolari A, Dionigi G, Boni L, Biglioli F, Valdatta L, Droghetti A, Bozzani A, Setacci C, Ravelli P, Crescini C, Staurenghi G, Scarone P, Francetti L, D'Angelo F, Gadda F, Comel A, Salvi L, Lorini L, Antonelli M, Bovenzi F, Cremonesi A, Angiolillo DJ, Guagliumi G; Italian Society of Invasive Cardiology (SICI-GISE); Italian Association of Hospital Cardiologists (ANMCO); Italian Society for Cardiac Surgery (SICCH); Italian Society of Vascular and Endovascular Surgery (SICVE); Italian Association of Hospital Surgeons (ACOI); Italian Society of Surgery (SIC); Italian Society of Anaesthesia and Intensive Care Medicine (SIAARTI); Lombard Society of Surgery (SLC); Italian Society of Maxillofacial Surgery (SICMF); Italian Society of Reconstructive Plastic Surgery and Aesthetics (SICPRE); Italian Society of Thoracic Surgeons (SICT); Italian Society of Urology (SIU); Italian Society of Orthopaedics and Traumatology (SIOT); Italian Society of Periodontology (SIdP); Italian Federation of Scientific Societies of Digestive System Diseases Lombardia (FISMAD); Association of Obstetricians Gynaecologists Italian Hospital Lombardia (AOGOI); Society of Ophthalmology Lombardia (SOL). Perioperative management of antiplatelet therapy in patients with coronary stents undergoing cardiac and non-cardiac surgery: a consensus document from Italian cardiological, surgical and anaesthesiological societies. EuroIntervention. 2014 May;10(1):38-46. doi: 10.4244/EIJV10I1A8.

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Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT03981835     History of Changes
Other Study ID Numbers: STU-2018-0398
First Posted: June 11, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No