An observational study in Cardiac Surgery, Surgery and Percutaneous Coronary Intervention, sponsored by Baylor Research Institute. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-06.
Sponsored by Baylor Research Institute · Observational
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 eligible NCS or CS :
Study eligible non-cardiac surgeries and procedures:
Study eligible cardiac surgeries and procedures
Baylor Research Institute is the lead sponsor of 219 studies on the registry; 49 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.
Counted across the registry records on this site, refreshed daily.
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).
Exclusion Criteria:
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 (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.
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.
Time frame: 2 weeks prior to surgery to up to 30 days post-surgery
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.
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.
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
Time to NACE
Time to NACE
Time frame: 2 weeks prior to surgery to up to 30 days post-surgery
All-cause mortality
All-cause mortality
Time frame: 2 weeks prior to surgery to up to 30 days post-surgery
Incidence of definite and probable stent thrombosis (ST).
Incidence of definite and probable stent thrombosis (ST).
Time frame: 2 weeks prior to surgery to up to 30 days post-surgery
Length of hospital stay (LOS).
Length of hospital stay (LOS).
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.
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
Plan to share: No
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Baylor Research Institute