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NCT03695159 · ClinicalTrials.gov registry record

The Perioperative Management of Anti-thrombotic Drug Registry

A clinical trial, sponsored by University of Texas Southwestern Medical Center.

Completed
Registry status
288
Enrollment target

NCT03695159 is a clinical trial that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 288 participants.

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The verdict

NCT03695159 has completed, sponsored by University of Texas Southwestern Medical Center.

COMPLETED
Registry status
288 participants
Enrollment target

Study Summary

The purpose of the study is to investigate contemporary antiplatelet therapy management of patients referred for non-cardiac and cardiac surgical procedures while on chronic therapy with antiplatelet and/or anticoagulant drugs. These medications are routinely prescribed to patients following percutaneous coronary interventions (PCI), known diagnosis of atrial fibrillation, prosthetic heart valves, transcatheter aortic valve procedures, pulmonary embolism, deep vein thrombosis, peripheral artery revascularization procedures etc. This is a highly relevant and understudied clinical area with no randomized clinical trials or large-scale prospective evidence, except for bridging data with unfractionated heparin (UFH). Most recommendations and guidelines are based on consensus expert opinion. While post-PCI patients, especially those treated with coronary stents are placed on dual antiplatelet agents such as aspirin and P2Y12 blocking agents, performing surgery while on these agents increase the risk of hemorrhagic complications, discontinuation or interruption of dual antiplatelet therapy (DAPT) has been associated with adverse ischemic outcomes secondary to myocardial infarction (MI) and stent thrombosis (ST). Moreover, there is only no clear consensus regarding continuation of aspirin perioperatively in these patients. As in the case of PCI, similar arguments for juxtaposed risks (thrombosis vs. bleeding) can be made for a myriad of clinical situations where chronic (≥45 days) use antiplatelet and anticoagulant medication (together referred to as antithrombotic drugs) are indicated. In addition, there are many procedures and surgeries with different bleeding and ischemic risks that cannot be studies through dedicated randomized studies and a registry collection of such information could provide valuable guidance to providers and patients worldwide.

Trial Details

FieldValue
Enrollment Target 288 participants
Start Date 2018-01-31
Est. Completion 2020-04-16

What the Registry Record Tells You About NCT03695159

The ClinicalTrials.gov registry entry for NCT03695159 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 288 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 0 interventions.

NCT03695159 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03695159 about?

NCT03695159 is a clinical study titled "The Perioperative Management of Anti-thrombotic Drug Registry". The purpose of the study is to investigate contemporary antiplatelet therapy management of patients referred for non-cardiac and cardiac surgical procedures while on chronic therapy with antiplatelet and/or anticoagulant drugs. These medications are routinely prescribed to patients following percuta...

What is the current status of trial NCT03695159?

This trial is currently completed. The enrollment target is 288 participants. The study started on 2018-01-31. Estimated completion is 2020-04-16.

Who is sponsoring clinical trial NCT03695159?

This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.