The Perioperative Management of Anti-thrombotic Drug Registry (CNCS)
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| ClinicalTrials.gov Identifier: NCT03695159 |
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Recruitment Status :
Active, not recruiting
First Posted : October 3, 2018
Last Update Posted : June 1, 2021
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Sponsor:
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
Subhash Banerjee, University of Texas Southwestern Medical Center
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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 |
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| Surgery Perioperative/Postoperative Complications |
| Study Type : | Observational [Patient Registry] |
| Actual Enrollment : | 288 participants |
| Observational Model: | Case-Only |
| Time Perspective: | Other |
| Target Follow-Up Duration: | 30 Days |
| Official Title: | The Perioperative Management of Anti-thrombotic Drug Registry |
| Actual Study Start Date : | January 31, 2018 |
| Estimated Primary Completion Date : | January 31, 2028 |
| Estimated Study Completion Date : | January 31, 2028 |
Primary Outcome Measures :
- Clinical Outcomes (Net Adverse Cardiovascular events (%)) [ Time Frame: 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)
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| 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)
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03695159
Locations
| United States, Texas | |
| North Texas VA Health Care System | |
| Dallas, Texas, United States, 75216 | |
| 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 |
Additional Information:
Publications:
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: | October 3, 2018 Key Record Dates |
| Last Update Posted: | June 1, 2021 |
| Last Verified: | May 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| 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, University of Texas Southwestern Medical Center:
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anti-thrombotic drugs cardiac intervention Non-cardiac intervention |
Additional relevant MeSH terms:
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Postoperative Complications Pathologic Processes |