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| Name | Class |
|---|---|
| Liverpool Heart and Chest Hospital NHS Foundation Trust | OTHER |
| Countess of Chester NHS Foundation Trust | OTHER |
| St Helens & Knowsley Teaching Hospitals NHS Trust | OTHER |
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A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.
Major bleeding after myocardial infarction portends a poor outcome. A balance is required between potency of platelet inhibition and risk of bleeding. Ticagrelor provides faster and more effective platelet inhibition than Clopidogrel. In the PLATO trial Ticagrelor reduced the incidence of cardiovascular death, myocardial infarction and stroke compared to Clopidogrel after ACS (acute coronary syndrome). Although there was no difference in overall bleeding there was more non-CABG related major bleeding with Ticagrelor. It has since been recommended, in addition to aspirin, in treatment of moderate-high risk ACS by both ESC (European Society of Cardiology) and NICE (National Institute for Clinical Excellence). There has been widespread adoption as first line therapy in UK hospitals. There remains potential concern about bleeding in a "real world" population compromising more high risk patients; particularly more elderly and female, than those in PLATO. The investigators intend to perform a large "real world" comparison of bleeding risk with Ticagrelor compared to Clopidogrel in a UK ACS population. The investigators plan an observational cohort study of patients presenting with ACS at 5 district general hospitals in Merseyside and Cheshire. The investigators will collect data retrospectively on 2500 patients treated with Clopidogrel prior to the guideline change and 2500 treated with Ticagrelor thereafter. The primary end point will be incidence of BARC 3-5 (Bleeding Academic Research Consortium) and PLATO major bleeding.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clopidogrel Group | Those patients treated with clopidogrel for ACS (before new guideline implementation) | ||
| Ticagrelor Group | Those patients treated with ticagrelor for ACS (after new guideline implementation) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ticagrelor | Drug | No intervention- purely observational |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions | bleeding event | 12 months from treatment starting |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of minor bleeding as defined by BARC and PLATO | Minor bleeding | 12 months from treatment starting |
| Incidence of gastrointestinal bleeding | GI bleeding |
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Inclusion Criteria:
1. Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.
Exclusion Criteria:
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All-comers treated for ACS above the age of 18 with either clopidogrel or ticagrelor
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| Name | Affiliation | Role |
|---|---|---|
| Aleem Khand, MBChB MRCP | University Hospital Aintree | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Aintree | Liverpool | L97AL | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39979827 | Derived | Mullen L, Stables R. Validation of HES coding for the detection of major bleeding events: insights from the ROBOT-ACS study. BMC Med Res Methodol. 2025 Feb 20;25(1):42. doi: 10.1186/s12874-025-02503-7. | |
| 33834845 | Derived | Mullen L, Meah MN, Elamin A, Aggarwal S, Shahzad A, Shaw M, Hasara J, Rashid M, Fisher M, Ali T, Patel B, Ding WY, Grainger R, Heseltine T, Kirmani BH, Obeidat M, Kasolo Y, Thatchil J, Khand A. Risk of Major Bleeding With Potent Antiplatelet Agents After an Acute Coronary Event: A Comparison of Ticagrelor and Clopidogrel in 5116 Consecutive Patients in Clinical Practice. J Am Heart Assoc. 2021 Apr 20;10(8):e019467. doi: 10.1161/JAHA.120.019467. Epub 2021 Apr 9. |
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| 12 months from treatment starting |
| Incidence of intracranial bleeding | intracranial bleeding | 12 months from treatment starting |
| Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death | MACE/ischaemic events | 12 months from treatment starting |
| Mortality | all cause mortality | 12 months from treatment starting |
| ID | Term |
|---|---|
| D054058 | Acute Coronary Syndrome |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077486 | Ticagrelor |
| D000077144 | Clopidogrel |
| ID | Term |
|---|---|
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| D013988 | Ticlopidine |
| D058924 | Thienopyridines |
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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