SurgeryCNCSNCT03695159
The Perioperative Management of Anti-thrombotic Drug Registry
An observational study of Surgery and Perioperative/Postoperative Complications, run by University of Texas Southwestern Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery, Perioperative/Postoperative Complications
- How many people
- 288 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Jan 2018to 16 Apr 2020
- How long will I take part?
- 30 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on chronic antiplatelet and anticoagulant therapies and undergo a cardiac and non-cardiac surgeries and procedures (CNCS)
Who may be able to join
- 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)
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
North Texas VA Health Care System
Dallas, Texas, 75216
UT Southwestern Medical Center
Dallas, Texas, 75390
About this study
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
- Medical subject headings
- Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: time of study reporting initiation (14 days prior to CNCS) to end of study (30 days post-CNCS).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start31 Jan 2018
- Primary completion30 Mar 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 288 participants (actual)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Subhash Banerjee, University of Texas Southwestern Medical Center
- Investigators
- Subhash Banerjee, MD, Study chair, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03695159
- Sponsor's protocol ID
- STU 012018-005
- Acronym
- CNCS
- Status last verified
- Feb 2024
- First submitted
- 20 Aug 2018
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23625942Beyer-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.
PubMed 24394381Douketis 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.
PubMed 26095867Tsimikas 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.
PubMed 16697332Cruden 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.
PubMed 20442357
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Perioperative Management of Anti-thrombotic Drug Registry
- ClinicalTrials.gov ID
- NCT03695159
- Acronym / sponsor ID
- CNCS / STU 012018-005
- Conditions
- Surgery, Perioperative/Postoperative Complications
- Keywords
- anti-thrombotic drugs, cardiac intervention, Non-cardiac intervention
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 31 Jan 2018 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Target follow-up
- 30 Days
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on chronic antiplatelet and anticoagulant therapies and undergo a cardiac and non-cardiac surgeries and procedures (CNCS)
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Background: PubMed 23625942Heidbuchel 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.
- Background: PubMed 24394381Beyer-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.
- Background: PubMed 26095867Douketis 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.
- Background: PubMed 16697332Tsimikas 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.
- Background: PubMed 20442357Cruden 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subhash Banerjee, MD study chair
University of Texas Southwestern Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery and Perioperative/Postoperative Complications, run by University of Texas Southwestern Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03695159, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.