Management of Antiplatelet Regimen During Surgical Procedures

Completed

Conditions studied: Cardiac Surgery, Surgery, Percutaneous Coronary Intervention, Surgery--Complications

In brief

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.

Key facts

Study ID

NCT03981835

Run by

Baylor Research Institute

People needed

147

Starts

2019-08-01

Expected to finish

2024-01-30

Last updated by the study team

2026-02-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

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

Where it is running

• University of Florida — Jacksonville, Florida, United States
• Dallas VA Medical Center — Dallas, Texas, United States
• Baylor Scott & White Research Institute — Dallas, Texas, United States
• UT Southwestern Medical Center — Dallas, Texas, United States
• Mary Washington Hospital — Fredericksburg, Virginia, United States

Full record on ClinicalTrials.gov

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