Patient Characteristics, Persistence to Treatment and Outcome Events in Patients Treated With Ticagrelor 60 mg After Myocardial Infarction in Real-world Clinical Practice

NCT04568083 | Completed

• 1 other identifier: D5130R00057
• Study Type: observational
• Target: 7,035
• Locations: 5 countries
• Sites: 6

Brief Summary

This is an observational study based on secondary data extracted from multiple register-based data sources in the US and Europe (Sweden, United Kingdom, Italy, Germany). The study will include patients initiating treatment with ticagrelor 60 mg after a myocardial infarction in real-world clinical practice, and describe their patient characteristics and duration of treatment. If the a priori threshold of 5,000 person-years on treatment with ticagrelor 60 mg is met, outcome events (bleeding and cardiovascular events) will also be analysed and described.

Conditions

Myocardial Infarction (MI)

Keywords

Myocardial Infarction; Ticagrelor 60 mg; Antiplatelet agents; Medication persistence; Drug utilization; Bleeding; MACE; Cardiovascular; Cohort study; Observational study; Real-world evidence

Outcome Measures

Primary Outcomes (2)

• Treatment persistence

  Treatment discontinuation is defined on the basis of calculated days of supply from prescription data.

  From initiation of ticagrelor 60 mg to discontinuation, switch or death, assessed throughout the study period up to a maximum of 36 months

• Incidence of Major bleeding

  Major bleeding is defined as bleeding requiring hospitalisation.

  From initiation of ticagrelor 60 mg until the date of a major bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months

Secondary Outcomes (2)

• Incidence of Bleeding events

  From initiation of ticagrelor 60 mg until the date of a bleeding event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months

• Incidence of Cardiovascular (CV) events

  From initiation of ticagrelor 60 mg until the date of a CV event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months

Other Outcomes (2)

• Incidence of Dyspnoea

  From initiation of ticagrelor 60 mg until the date of a dyspnoea event, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months

• Incidence of Amputation (lower-limb)

  From initiation of ticagrelor 60 mg until the date of amputation of lower limb, assessed throughout the study period until treatment discontinuation or end of follow-up, up to a maximum of 36 months

Study Arms (2)

Ticagrelor cohort

Patients initiating ticagrelor 60 mg after an MI, with no prescription of ticagrelor 60 mg prior to their qualifying MI. The qualifying MI is defined as the most recent MI occurring before the first ticagrelor 60 mg prescription.

Non-ticagrelor cohort

Patients not prescribed ticagrelor 60 mg at a comparable time point after an MI as matched patients in the ticagrelor cohort. Patients may be prescribed another P2Y12 inhibitor or aspirin alone.

Eligibility Criteria

• Age: Up to 130 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include patients who are hospitalised with a primary diagnosis of MI, identified using diagnostic codes, divided into cohorts receiving and not receiving treatment with ticagrelor 60 mg. Co-prescription of aspirin will also be identified where available.

You may qualify if:

• Primary Analysis Population:
• Hospitalisation with a primary diagnosis of MI during the eligibility period
• Ticagrelor cohort: A first prescription of ticagrelor 60 mg after the most recent hospitalisation with a primary diagnosis of MI.
• Non-ticagrelor cohort: A prescription of clopidogrel, prasugrel or ticlopidine, or no prescription for any of these medications, at a comparable timepoint relative to their MI as for the ticagrelor cohort
• Secondary Analysis Population:
• The qualifying prescription 12-36 months after a hospitalisation with a primary diagnosis of MI and treatment with an ADP receptor antagonist (clopidogrel, prasugrel, ticagrelor 90 mg, ticlopidine) ≤12 months prior to the qualifying prescription, or the qualifying prescription 12-24 months after a hospitalisation with a primary diagnosis of MI AND
• Age ≥50 years
• At least one of the following risk factors:
• Age ≥ 65 years
• Diabetes mellitus requiring medication
• A second prior MI
• Evidence of multivessel coronary artery disease
• Chronic non-end-stage renal dysfunction

You may not qualify if:

• Applicable to the Primary and Seconday Analysis Populations:
• Dies, emigrates, or disenrolls from the database (where applicable) prior to the ticagrelor approval date.
• Ineligibility for ticagrelor use (restricted to the conditions possible to capture within the data sources)-one or more of the following:
• Concomitant use of an anticoagulant
• Prior ischaemic stroke
• Prior history of intracranial bleeding
• Severe hepatic impairment
• Gastrointestinal bleeding
• Renal failure requiring dialysis
• Concomitant use of a strong CYP3A4 inhibitor or inducer
• \<1 year of data available prior to the qualifying MI (for assessment of patient characteristics at qualifying MI)

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (6)

Research Site

Bethesda, Maryland, 20814, United States

Location

Research Site

Waltham, Massachusetts, 02451, United States

Location

Research Site

Wismar, Germany

Location

Research Site

Rome, Italy

Location

Research Site

Stockholm, Sweden

Location

Research Site

London, United Kingdom

Location

Related Publications (1)

• Bonaca MP, Lesen E, Giannitsis E, Hedberg J, Jernberg T, Lambrelli D, Duong M, Maggioni AP, Ariza-Sole A, Ten Berg J, Storey RF. Characteristics and outcomes in patients with a prior myocardial infarction treated with extended dual antiplatelet therapy with ticagrelor 60 mg: findings from ALETHEIA, a multi-country observational study. Eur Heart J Cardiovasc Pharmacother. 2023 Dec 14;9(8):701-708. doi: 10.1093/ehjcvp/pvad062.

  PMID: 37653447 DERIVED

Related Links

• CSR Synopsis

MeSH Terms

Conditions

Myocardial Infarction; Medication Adherence; Hemorrhage

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

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

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: September 29, 2020
• Study Start: September 25, 2020
• Primary Completion: June 28, 2021
• Study Completion: June 28, 2021
• Last Updated: April 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure
• Access Criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Locations

IT (1); DE (1); SE (1); US (2); GB (1)