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| Name | Class |
|---|---|
| University of Leeds | OTHER |
| Erasmus Medical Center | OTHER |
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Research questions:
In brief the design of the study is as follows:
This study will compare the use of aspirin alone with dual antiplatelet therapy (i.e. aspirin and clopidogrel) in patients presenting for elective non-cardiac surgery who have undergone PCI with either bare metal stent or drug eluting stent placement in the four years prior to surgery. The absolute risk reduction in major adverse cardiac events (MACE) with dual antiplatelet therapy and the absolute risk increase for clinically significant bleeding events with dual therapy will be determined. This will allow the number needed to treat (NNT) for the prevention of MACE and the number needed to harm (NNH) for bleeding to be determined and the optimal antiplatelet therapy in this setting to be identified.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In Patients |
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| Measure | Description | Time Frame |
|---|---|---|
| 1. MACE | This study will record and analyse in-hospital adverse cardiac events. Major Adverse Cardiac Events (MACE) will be defined as a composite of:
| In-hospital stay up to 30 days |
| 2. Clinically significant bleeding | This study will record and analyse in-hospital clinically significant bleeding. Clinically Significant Bleeding Events will be defined as:
| In-hospital stay up to 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing non-cardiac surgery within four years of percutaneous coronary intervention (PCI) with the placement of a bare metal or drug eluting stent will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Simon Howell, MD | Sectional of Translational Anaesthetic and Surgical Sciences, University of Leeds, United Kingdom | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Carl Gustav Carus | Dresden | 01307 | Germany | |||
| Erasmus University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21544024 | Background | Howell SJ, Hoeks SE, Poldermans D, West RM, Wheatcroft SB. OBTAIN: a study of the occurrence of bleeding and thrombosis during anti-platelet therapy in non-cardiac surgery. Eur J Anaesthesiol. 2011 Jun;28(6):456-9. doi: 10.1097/EJA.0b013e328344b4fc. No abstract available. |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D013927 | Thrombosis |
| D002318 | Cardiovascular Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| Rotterdam |
| Netherlands |
| University of Leeds, Sectional of Translational Anaesthetic and Surgical Sciences | Leeds | LS9 7TF | United Kingdom |