Acute Coronary SyndromeROBOT-ACSNCT02484924
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
An observational study of Acute Coronary Syndrome and Bleeding, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Bleeding, Novel Anti-platelets
- What is being tested?
- Ticagrelor
- How many people
- 5,225 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2010to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All-comers treated for ACS above the age of 18 with either clopidogrel or ticagrelor
Who may be able to join
- 1. Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
A retrospective real world analysis of bleeding events with ticagrelor compared to clopidogrel in ACS patients.
Read the 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.
- Conditions
- Acute Coronary Syndrome, Bleeding, Novel Anti-platelets, Ticagrelor, Clopidogrel
- Being tested
- Ticagrelor
- Medical subject headings
- Acute Coronary Syndrome, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Clopidogrel
No intervention- purely observational
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Drug: Ticagrelor |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions
bleeding event
Measured: 12 months from treatment starting
Secondary outcomes (5)
Incidence of minor bleeding as defined by BARC and PLATO
Minor bleeding
Measured: 12 months from treatment starting
Incidence of gastrointestinal bleeding
GI bleeding
Measured: 12 months from treatment starting
Incidence of intracranial bleeding
intracranial bleeding
Measured: 12 months from treatment starting
Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death
MACE/ischaemic events
Measured: 12 months from treatment starting
Mortality
all cause mortality
Measured: 12 months from treatment starting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJun 2010
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 5,225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool University Hospitals NHS Foundation Trust
- Sponsor type
- Other government
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Countess of Chester NHS Foundation Trust, St Helens & Knowsley Teaching Hospitals NHS Trust
- Responsible party
- Sponsor
- Investigators
- Aleem Khand, MBChB MRCP, Principal investigator, University Hospital Aintree
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02484924
- Sponsor's protocol ID
- 680/15
- Acronym
- ROBOT-ACS
- Status last verified
- Jan 2016
- First submitted
- 26 Jun 2015
- Last updated
- 9 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39979827Mullen 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.
PubMed 33834845
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02484924
- Acronym / sponsor ID
- ROBOT-ACS / 680/15
- Conditions
- Acute Coronary Syndrome, Bleeding, Novel Anti-platelets, Ticagrelor, Clopidogrel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,225 participants (actual)
- Lead sponsor
- Liverpool University Hospitals NHS Foundation TrustOther government
- Collaborators
- Liverpool Heart and Chest Hospital NHS Foundation Trust, Countess of Chester NHS Foundation Trust, St Helens & Knowsley Teaching Hospitals NHS Trust
- Study start
- Jun 2010
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel Group | – | –Those patients treated with clopidogrel for ACS (before new guideline implementation) |
| Ticagrelor Group | – | Drug: TicagrelorThose patients treated with ticagrelor for ACS (after new guideline implementation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All-comers treated for ACS above the age of 18 with either clopidogrel or ticagrelor
Key inclusion criteria (1 listed)
- 1. Patient commenced on clopidogrel for ACS prior to change of ACS guidelines, or tiacgrelor for same indication afterwards.
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: ClopidogrelNo intervention- purely observational | Drug | Ticagrelor Group |
Primary outcome
The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions
Time frame: 12 months from treatment starting
bleeding event
5 secondary outcomes
Incidence of minor bleeding as defined by BARC and PLATO
Time frame: 12 months from treatment starting
Incidence of gastrointestinal bleeding
Time frame: 12 months from treatment starting
Incidence of intracranial bleeding
Time frame: 12 months from treatment starting
Rate of major adverse cardiovascular events; myocardial infarction, stroke and cardiovascular death
Time frame: 12 months from treatment starting
Mortality
Time frame: 12 months from treatment starting
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Derived from this study: PubMed 39979827Mullen 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.
- Derived from this study: PubMed 33834845Mullen 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleem Khand, MBChB MRCP principal investigator
University Hospital Aintree
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Bleeding, run by Liverpool University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of major bleeding defined by both BARC (3-5) and PLATO definitions (time frame: 12 months from treatment starting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02484924, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2022.