Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)

Status: Recruiting
Location: See all (5) locations...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Florida
University of Florida
RECRUITING
Jacksonville
Texas
Baylor Scott & White Research Institute
RECRUITING
Dallas
Dallas VA Medical Center
COMPLETED
Dallas
UT Southwestern Medical Center
COMPLETED
Dallas
Virginia
Mary Washington Hospital
COMPLETED
Fredericksburg
Contact Information
Primary
Subhash Banerjee, MD
subhash.banerjee@bswhealth.org
469-800-7400
Backup
David Fernandez Vazquez, MD
David.FernandezVazquez@BSWHealth.org
214-820-2928
Time Frame
Start Date: 2019-08-01
Estimated Completion Date: 2025-03-19
Participants
Target number of participants: 1492
Treatments
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.
Authors
Hurst Hall
Sponsors
Leads: Baylor Research Institute

This content was sourced from clinicaltrials.gov