COMPLETED

Management of Antiplatelet Regimen During Surgical Procedures

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)

Quick Facts

Study Start:2019-08-01
Study Completion:2024-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03981835

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with PCI within the past 2 years who: a. Are currently on DAPT, OR b. Have a current indication for DAPT
  2. * Scheduled for NCS or CS.
  3. * Willing and able to provide an informed consent (if needed based on institutional IRB requirements).
  1. * Emergent (6 hours) surgery post-PCI on DAPT that precludes a thorough informed consent process.

Contacts and Locations

Principal Investigator

Subhash Banerjee, MD
STUDY_CHAIR
Baylor Scott & White Research Institute

Study Locations (Sites)

University of Florida
Jacksonville, Florida, 32209
United States
Dallas VA Medical Center
Dallas, Texas, 75216
United States
Baylor Scott & White Research Institute
Dallas, Texas, 75226
United States
UT Southwestern Medical Center
Dallas, Texas, 75390
United States
Mary Washington Hospital
Fredericksburg, Virginia, 22401
United States

Collaborators and Investigators

Sponsor: Baylor Research Institute

  • Subhash Banerjee, MD, STUDY_CHAIR, Baylor Scott & White Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-08-01
Study Completion Date2024-01-30

Study Record Updates

Study Start Date2019-08-01
Study Completion Date2024-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiac Surgery
  • Surgery
  • Percutaneous Coronary Intervention
  • Surgery--Complications