The Perioperative Management of Anti-thrombotic Drug Registry

NCT03695159 | Completed

• 1 other identifier: STU 012018-005
• Study Type: observational
• Target: 288
• Locations: 1 country
• Sites: 2

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.

Conditions

Surgery; Perioperative/Postoperative Complications

Keywords

anti-thrombotic drugs; cardiac intervention; Non-cardiac intervention

Outcome Measures

Primary Outcomes (1)

• Clinical Outcomes (Net Adverse Cardiovascular events (%))

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

  time of study reporting initiation (14 days prior to CNCS) to end of study (30 days post-CNCS).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients on chronic antiplatelet and anticoagulant therapies and undergo a cardiac and non-cardiac surgeries and procedures (CNCS)

You may qualify if:

• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (2)

North Texas VA Health Care System

Dallas, Texas, 75216, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Related Publications (5)

• Heidbuchel H, Verhamme P, Alings M, Antz M, Hacke W, Oldgren J, Sinnaeve P, Camm AJ, Kirchhof P; European Heart Rhythm Association. European Heart Rhythm Association Practical Guide on the use of new oral anticoagulants in patients with non-valvular atrial fibrillation. Europace. 2013 May;15(5):625-51. doi: 10.1093/europace/eut083.

  PMID: 23625942 BACKGROUND

• Beyer-Westendorf J, Gelbricht V, Forster K, Ebertz F, Kohler C, Werth S, Kuhlisch E, Stange T, Thieme C, Daschkow K, Weiss N. Peri-interventional management of novel oral anticoagulants in daily care: results from the prospective Dresden NOAC registry. Eur Heart J. 2014 Jul 21;35(28):1888-96. doi: 10.1093/eurheartj/eht557. Epub 2014 Jan 6.

  PMID: 24394381 BACKGROUND

• Douketis JD, Spyropoulos AC, Kaatz S, Becker RC, Caprini JA, Dunn AS, Garcia DA, Jacobson A, Jaffer AK, Kong DF, Schulman S, Turpie AG, Hasselblad V, Ortel TL; BRIDGE Investigators. Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation. N Engl J Med. 2015 Aug 27;373(9):823-33. doi: 10.1056/NEJMoa1501035. Epub 2015 Jun 22.

  PMID: 26095867 BACKGROUND

• Tsimikas S. Drug-eluting stents and late adverse clinical outcomes lessons learned, lessons awaited. J Am Coll Cardiol. 2006 May 16;47(10):2112-5. doi: 10.1016/j.jacc.2006.03.019. Epub 2006 Apr 4. No abstract available.

  PMID: 16697332 BACKGROUND

• Cruden NL, Harding SA, Flapan AD, Graham C, Wild SH, Slack R, Pell JP, Newby DE; Scottish Coronary Revascularisation Register Steering Committee. Previous coronary stent implantation and cardiac events in patients undergoing noncardiac surgery. Circ Cardiovasc Interv. 2010 Jun 1;3(3):236-42. doi: 10.1161/CIRCINTERVENTIONS.109.934703. Epub 2010 May 4.

  PMID: 20442357 BACKGROUND

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Subhash Banerjee, MD

  University of Texas Southwestern Medical Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: October 3, 2018
• Study Start: January 31, 2018
• Primary Completion: March 30, 2020
• Study Completion: April 16, 2020
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)