Clinical trial NCT03981835: Management of Antiplatelet Regimen During Surgical Procedures
Official title: Management of Antiplatelet Regimen During Surgical Procedures (MARS Registry)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiac Surgery
Surgery
Percutaneous Coronary Intervention
Surgery--Complications
Lead sponsor: Baylor Research Institute
Sponsor class: OTHER
First posted: 2019-06-11
Enrollment: 1492
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: 1. Registry infrastructure: The proposed registry is a multicenter prospective registry that is designed to capture perioperative DAPT management strategies in patients undergoing NCS or CS post-PCI. It will be adjudicated and monitored for data accuracy and completeness. The registry will be de-identified and compliant with HIPPA regulations and will be located on secure servers of the University of Texas Southwestern Medical Center (UTSW). Full-time staff that includes an information technology officer and data programmer manages the registry servers professionally. The servers are backed up daily and provide on-line secure access to site investigators and coordinators. The current registry structure is already in use for a national peripheral artery disease registry and can be viewed at www.XLPAD.org. The MARS registry will include two separate registry arms to capture data on two distinct cohorts: (i) NCS and (ii) CS.
2. Hypothesis: This observational registry is designed to test whether 30-day NACE associated with IV APT bridging is ≥6%.
3. Study period: period of 14 days prior to surgery to 30 days post-surgery.
4. Study eligible NCS or CS :

   * Study eligible non-cardiac surgeries and procedures:

     1. Intra-abdominal surgery (e.g., bowel or visceral organ resection) \*
     2. Intra-thoracic surgery (e.g., lung resection) \*
     3. Major orthopedic surgery (e.g., hip or knee replacement)
     4. Peripheral arterial revascularization (e.g., aortic aneurysm repair\*, vascular bypass\*, carotid surgery)
     5. Urologic surgery (e.g., prostatectomy\*, bladder tumor resection);
     6. Major procedure (e.g., renal, lung or liver transplants\*, biopsy of lung, head and neck surgery\*)
     7. Breast and other surgeries or procedures requiring DAPT interruption as per the clinical team \*High-risk NCS, remaining classified as low-intermediate
   * Study eligible cardiac surgeries and procedures

     1. Coronary artery bypass graft (CABG)
     2. Cardiac valve repair or replacement with or without CABG
     3. Surgical arrhythmia treatment (MAZE procedure)
     4. Pericardial procedures
     5. Thoracoscopic procedures
     6. Other cardiothoracic procedures (please contact study tem)
5. Study population: Post-PCI patients on DAPT undergoing NCS and CS. Patients will be asked to sign an informed consent form (ICF) or ICF deferred based on the mandate of their respective institutional review boards (IRB).
6. Registry data collection: The registry will be built on the NHLBI's REDCap data collection portal that is available to UTSW under an Academic Information Systems NIH grant UL1-RR024982. The proposed MARS Registry data collection portal. The data collection portal has been designed to facilitate comprehensive data collection from 2 weeks prior to surgery to 30±7 days post-surgery and includes demographics, laboratory, coronary revascularization, medication and clinical outcome information. Baseline information will include demographic, relevant medical history, preoperative medications and laboratory values and any preoperative clinical events during the study period. Procedure related data will include surgical procedure details, intraoperative medications and medications, laboratory values and clinical outcomes from the day of surgery till hospital discharge. Postoperative data collection will include medications, laboratory values and clinical events between hospital discharge and 30 days post-discharge. Data will be entered into a secure and HIPPA compliant online REDCap data collection portal. No study related procedures, interventions or follow-ups are required. Each site staff will enter data based on electronic health records (EHR), which wills serve as the primary data source. Out of hospital medical records will need to be incorporated or documented as part of a given participants' source data. All participants will be given the opportunity to re-evaluate their decisions regarding participation in the MARS Registry. The MARS registry will include two separate arms of the registry to capture data on two distinct cohorts: (i) NCS and (ii) CS.

Eligibility 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.

Primary outcomes:
measure: Rate of Net adverse cardiovascular events (NACE) over the study period
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
Secondary outcomes:
measure: Incidence of individual components of NACE over the study period
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
measure: Incidence of IV antiplatelet (APT) bridging and comparison of IV APT bridging and no bridging strategies.
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
measure: Time to NACE
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
measure: All-cause mortality
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
measure: Incidence of definite and probable stent thrombosis (ST).
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
measure: Length of hospital stay (LOS).
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
measure: Health economic analysis comparing cost-effectiveness of IV APT bridging and no bridging strategies.
timeFrame: 2 weeks prior to surgery to up to 30 days post-surgery
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida
state: Florida
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Dallas
country: United States
facility: Baylor Scott & White Research Institute
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Fredericksburg
country: United States
facility: Mary Washington Hospital
state: Virginia
Study officials:
affiliation: Baylor Scott & White Research Institute
name: Subhash Banerjee, MD
role: STUDY_CHAIR
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