The Perioperative Management of Anti-thrombotic Drug Registry
| Tracking Information | |||
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| First Submitted Date ICMJE | August 20, 2018 | ||
| First Posted Date ICMJE | October 3, 2018 | ||
| Last Update Posted Date | October 3, 2018 | ||
| Actual Study Start Date ICMJE | January 31, 2018 | ||
| Estimated Primary Completion Date | January 31, 2028 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
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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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | The Perioperative Management of Anti-thrombotic Drug Registry |
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| Official Title ICMJE | The Perioperative Management of Anti-thrombotic Drug Registry |
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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. |
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| Detailed Description | |||
| Study Type ICMJE | Observational [Patient Registry] | ||
| Study Phase | |||
| Study Design ICMJE | Allocation: Intervention Model: Intervention Model Description: Masking: Observational [Patient Registry] Masking Description: Primary Purpose: |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
12000 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | January 31, 2028 | ||
| Estimated Primary Completion Date | January 31, 2028 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | 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: | ||
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| Ages | 18 Years and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United States | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | No | |
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Subhash Banerjee，University of Texas Southwestern Medical Center | ||
| Study Sponsor ICMJE | Subhash Banerjee | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | University of Texas Southwestern Medical Center | ||
| Verification Date | October 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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