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Completed

NCT Number: 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

A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Aintree

Liverpool, L97AL, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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)

Treatment and study plan

Ticagrelor

Drug

No intervention- purely observational

Other names: Clopidogrel

Primary outcomes

  1. The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions

    Time frame: 12 months from treatment starting

    bleeding event

Secondary outcomes

  1. Incidence of minor bleeding as defined by BARC and PLATO

    Time frame: 12 months from treatment starting

    Minor bleeding

  2. Incidence of gastrointestinal bleeding

    Time frame: 12 months from treatment starting

    GI bleeding

  3. Incidence of intracranial bleeding

    Time frame: 12 months from treatment starting

    intracranial bleeding

  4. Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death

    Time frame: 12 months from treatment starting

    MACE/ischaemic events

  5. Mortality

    Time frame: 12 months from treatment starting

    all cause mortality

Sponsors and collaborators

Lead sponsor

Liverpool University Hospitals NHS Foundation Trust

Other Gov

Collaborators

  • Countess of Chester NHS Foundation Trust
  • Liverpool Heart and Chest Hospital NHS Foundation Trust
  • St Helens & Knowsley Teaching Hospitals NHS Trust

Registry information

Acronym: ROBOT-ACS

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2015
Registry last updated
Jun 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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