The Risk of Major Bleeding With Novel Anti-platelets: A Comparison of Ticagrelor With Clopidogrel in a Real World Population of 5000 Patients Treated for Acute Coronary Syndrome
- Conditions
- TicagrelorClopidogrelAcute Coronary SyndromeBleedingNovel Anti-platelets
- Interventions
- Registration Number
- NCT02484924
- Brief Summary
A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 5225
- Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.
- Patient already taking the drug in question (clopidogrel or ticagrelor) prior to the ACS event
- Patients under 18 years of age
- Patients in whom the drug is stopped during the same hospital admission due to clinical judgement dictating that it is no longer indicated (this does not apply to patients in whom a bleeding event is the precipitant for stopping the drug)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ticagrelor Group Ticagrelor Those patients treated with ticagrelor for ACS (after new guideline implementation)
- Primary Outcome Measures
Name Time Method The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions 12 months from treatment starting bleeding event
- Secondary Outcome Measures
Name Time Method Incidence of minor bleeding as defined by BARC and PLATO 12 months from treatment starting Minor bleeding
Incidence of intracranial bleeding 12 months from treatment starting intracranial bleeding
Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death 12 months from treatment starting MACE/ischaemic events
Mortality 12 months from treatment starting all cause mortality
Incidence of gastrointestinal bleeding 12 months from treatment starting GI bleeding
Trial Locations
- Locations (1)
University Hospital Aintree
🇬🇧Liverpool, United Kingdom