Clincosm LogoSign in Get a demo

CNCS: The Perioperative Management of Anti-thrombotic Drug Registry

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03695159
Collaborator
(none)
288
Enrollment
2
Locations
120
Anticipated Duration (Months)
144
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    288 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Other
    Official Title:
    The Perioperative Management of Anti-thrombotic Drug Registry
    Actual Study Start Date :
    Jan 31, 2018
    Anticipated Primary Completion Date :
    Jan 31, 2028
    Anticipated Study Completion Date :
    Jan 31, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Outcomes (Net Adverse Cardiovascular events (%)) [time of study reporting initiation (14 days prior to CNCS) to end of study (30 days post-CNCS).]

      A composite of Death, Non-Fatal MI, Ischemic Stroke, Need for Urgent Coronary Revascularization, and Bleeding (defined by Bleeding Associated Research Consortium- BARC)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Treatment with antiplatelet and/or anticoagulant medications for ≥45 days prior to the date of NCS.

    • Patients with planned, urgent or emergent cardiac or non-cardiac surgery or procedure (CNCS)

    Exclusion Criteria:
    • None

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 North Texas VA Health Care System Dallas Texas United States 75216
    2 UT Southwestern Medical Center Dallas Texas United States 75390

    Sponsors and Collaborators

    • University of Texas Southwestern Medical Center

    Investigators

    • Study Chair: Subhash Banerjee, MD, UT Southwestern Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Subhash Banerjee, Professor of Medicine, University of Texas Southwestern Medical Center
    ClinicalTrials.gov Identifier:
    NCT03695159
    Other Study ID Numbers:
    • STU 012018-005
    First Posted:
    Oct 3, 2018
    Last Update Posted:
    May 11, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Subhash Banerjee, Professor of Medicine, University of Texas Southwestern Medical Center
    anti-thrombotic drugs
    cardiac intervention
    Non-cardiac intervention
    Additional relevant MeSH terms:
    Postoperative Complications

    Study Results

    No Results Posted as of May 11, 2022