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

Acute Coronary Syndrome Clinical Trial

— ROBOT-ACS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02484924
• Other study ID #: 680/15
• Status: Completed
• Start date: June 2010
• Est. completion date: June 2016

Study information

• Verified date: January 2016
• Source: Liverpool University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 5225
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Bleeding
• Clopidogrel
• Hemorrhage
• Novel Anti-platelets
• Syndrome
• Ticagrelor

Intervention

Drug:
• Ticagrelor
No intervention- purely observational

Locations

Country	Name	City	State
United Kingdom	University Hospital Aintree	Liverpool

Sponsors (4)

Lead Sponsor	Collaborator
Liverpool University Hospitals NHS Foundation Trust	Countess of Chester NHS Foundation Trust, Liverpool Heart and Chest Hospital NHS Foundation Trust, St Helens & Knowsley Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions	bleeding event	12 months from treatment starting
Secondary	Incidence of minor bleeding as defined by BARC and PLATO	Minor bleeding	12 months from treatment starting
Secondary	Incidence of gastrointestinal bleeding	GI bleeding	12 months from treatment starting
Secondary	Incidence of intracranial bleeding	intracranial bleeding	12 months from treatment starting
Secondary	Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death	MACE/ischaemic events	12 months from treatment starting
Secondary	Mortality	all cause mortality	12 months from treatment starting