Clinical trial NCT02484924: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Bleeding
Novel Anti-platelets
Ticagrelor
Clopidogrel
Lead sponsor: Liverpool University Hospitals NHS Foundation Trust
Sponsor class: OTHER_GOV
Collaborators: name: Liverpool Heart and Chest Hospital NHS Foundation Trust
name: Countess of Chester NHS Foundation Trust
name: St Helens & Knowsley Teaching Hospitals NHS Trust
First posted: 2015-06-30
Enrollment: 5225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All-comers treated for ACS above the age of 18 with either clopidogrel or ticagrelor

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.

Eligibility criteria: Inclusion Criteria:

1. Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.

Exclusion Criteria:

1. Patient already taking the drug in question (clopidogrel or ticagrelor) prior to the ACS event
2. Patients under 18 years of age
3. 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)

Primary outcomes:
measure: The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions
timeFrame: 12 months from treatment starting
Secondary outcomes:
measure: Incidence of minor bleeding as defined by BARC and PLATO
timeFrame: 12 months from treatment starting
measure: Incidence of gastrointestinal bleeding
timeFrame: 12 months from treatment starting
measure: Incidence of intracranial bleeding
timeFrame: 12 months from treatment starting
measure: Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death
timeFrame: 12 months from treatment starting
measure: Mortality
timeFrame: 12 months from treatment starting
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: University Hospital Aintree
Study officials:
affiliation: University Hospital Aintree
name: Aleem Khand, MBChB MRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.