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

NCT02484924 | Completed

• 1 other identifier: 680/15
• Study Type: observational
• Target: 5,225
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Coronary Syndrome; Bleeding; Novel Anti-platelets; Ticagrelor; Clopidogrel

Outcome Measures

Primary Outcomes (1)

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

  bleeding event

  12 months from treatment starting

Secondary Outcomes (5)

• Incidence of minor bleeding as defined by BARC and PLATO

  12 months from treatment starting

• Incidence of gastrointestinal bleeding

  12 months from treatment starting

• Incidence of intracranial bleeding

  12 months from treatment starting

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

  12 months from treatment starting

• Mortality

  12 months from treatment starting

Study Arms (2)

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)

Drug: Ticagrelor

Interventions

Ticagrelor DRUG

No intervention- purely observational

Also known as: Clopidogrel

Ticagrelor Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All-comers treated for ACS above the age of 18 with either clopidogrel or ticagrelor

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

University Hospital Aintree

Liverpool, L97AL, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 39979827 DERIVED

• 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.

  PMID: 33834845 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Hemorrhage

Interventions

Ticagrelor; Clopidogrel

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Aleem Khand, MBChB MRCP

  University Hospital Aintree

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: June 30, 2015
• Study Start: June 1, 2010
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 9, 2022

Record last verified: 2016-01

Locations

GB (1)