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NCT03981835 · ClinicalTrials.gov registry record
Management of Antiplatelet Regimen During Surgical Procedures
A clinical trial of Surgery and Cardiac Surgery, sponsored by Baylor Research Institute.
- Completed
- Registry status
- 147
- Enrollment target
- 5
- Study locations
NCT03981835: Completed study of Surgery and Cardiac Surgery, sponsored by Baylor Research Institute.
NCT03981835 is a study of Surgery and Cardiac Surgery that has completed, run by Baylor Research Institute. The registered enrollment target is 147 participants, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower). The trial reports 5 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03981835, a study of Surgery and Cardiac Surgery, has completed, sponsored by Baylor Research Institute.
- COMPLETED
- Registry status
- 147 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Study Locations (5)
Texas
- Dallas VA Medical Center - Dallas
- Baylor Scott & White Research Institute - Dallas
- UT Southwestern Medical Center - Dallas
Florida
- University of Florida - Jacksonville
Virginia
- Mary Washington Hospital - Fredericksburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 147 participants |
| Start Date | 2019-08-01 |
| Est. Completion | 2024-01-30 |
What the finished NCT03981835 record still lists
NCT03981835 is an observational study that tracks outcomes without assigning an intervention. The registered 147 participants enrollment target is mid-sized for trials with a published cap, below the 52,851-participant average among 120 other Surgery trials with a reported enrollment target (100% lower).
The record links to 4 conditions, with Surgery appearing as the primary indexed condition, and to 0 interventions.
NCT03981835 lists 5 locations in 3 states (Texas, Florida, Virginia).
Frequently Asked Questions
What is clinical trial NCT03981835 about?
NCT03981835 is a clinical study titled "Management of Antiplatelet Regimen During Surgical Procedures". 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 studie...
What is the current status of trial NCT03981835?
This trial is currently completed. The enrollment target is 147 participants. The study started on 2019-08-01. Estimated completion is 2024-01-30.
What conditions does trial NCT03981835 study?
This clinical trial studies the following conditions: Surgery, Cardiac Surgery, Percutaneous Coronary Intervention, Surgery--Complications.
Who is sponsoring clinical trial NCT03981835?
This trial is sponsored by Baylor Research Institute, which has 180 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03981835 being conducted?
This trial has 5 study locations across Florida, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03981835's enrollment target sits among peer trials
147 48th of 120 higher than 73 of 120 other Surgery trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Surgery trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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