ADHerence of ticagrelOr in Real World Patients With aCute Coronary Syndrome (AD-HOC)

January 10, 2023 updated by: Fondazione per la Ricerca Ospedale Maggiore

Incidence and Models of Ticagrelor Discontinuation in Patients With Acute Coronary Syndrome

Ticagrelor 90 mg twice daily treatment is recommended for 12 months in patients with acute coronary syndrome (ACS) and in patients undergoing coronary revascularization and conservative strategies. Recent data from the PEGASUS-TIMI 541 trial have shown that long-term treatment with ticagrelor reduced the risk of major cardiovascular adverse events (MACE) in stable ambulatory patients with a history of myocardial infarction. Based on these data, prolongation over 12 months of ticagrelor therapy could be indicated in selected patients; even if with such a prolongation some adverse effects on the treatment could be observed. In the PLATO2 trial, where median duration of exposure to the study drug was 277 days, the suspension of ticagrelor therapy was 7.4% in ticagrelor versus 6% in patients receiving clopidogrel ( P <0.001). Ticagrelor treatment interruption was mainly driven by non-serious adverse events occurring mainly shortly after randomization. For patients after the first year of treatment, the subsequent rate of interruption was low. These data demonstrate that adverse events considered "not serious" by traditional trial criteria may have an effect on quality of life and, therefore, can cause treatment interruption; The phenomenon emphasizes at the same time the importance of patient education and advice on timing and the nature of adverse effects in order to improve adherence. Patients in the real world may show a premature suspension rate of the drug even higher than in clinical trials. However, data from real-world patients is scarce.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Ticagrelor 90 mg twice daily treatment is recommended for 12 months in patients with acute coronary syndrome (ACS) and in patients undergoing coronary revascularization and conservative strategies. Prolongation over 12 months of ticagrelor therapy could be indicated in selected patients; even if with such a prolongation some adverse effects on the treatment could be observed. In the PLATO2 trial, where median duration of exposure to the study drug was 277 days, the suspension of ticagrelor therapy was 7.4% in ticagrelor versus 6% in patients receiving clopidogrel ( P <0.001). Ticagrelor treatment interruption was mainly driven by non-serious adverse events occurring mainly shortly after randomization. For patients after the first year of treatment, the subsequent rate of interruption was low. These data demonstrate that adverse events considered "not serious" by traditional trial criteria may have an effect on quality of life and, therefore, can cause treatment interruption; The phenomenon emphasizes at the same time the importance of patient education and advice on timing and the nature of adverse effects in order to improve adherence. Patients in the real world may show a premature suspension rate of the drug even higher than in clinical trials. However, data from real-world patients is scarce.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
480

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All consecutive adult patients discharged from the hospital with a diagnosis of ACS and on ticagrelor therapy

Description

Inclusion Criteria:

  • Adult (>=18 years age) patients
  • Patients discharged from the hospital with a diagnosis of ACS
  • Patients discharged on ticagrelor therapy
  • Patients who have signed an informed consent to study participation

Exclusion Criteria:

  • Patients taking part in a study with a medical device or experimental drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of drug discontinuation
Time Frame: At 12 months
Ticagrelor discontinuation procedures include discontinuation, interruption and disruption. Discontinuation is defined as the definitive suspension recommended by physician for patients who are believed to no longer need ticagrelor. Interruption is defined as the temporary cessation of antiplatelet therapy for surgical needs with ticagrelor resumption after surgery. Disruption of therapy includes cessation of antiplatelet treatment due to bleeding or non-compliance
At 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of major adverse cardiac events (MACE)
Time Frame: At 12 months
Incidence of major adverse cardiac events (MACE)
At 12 months
Incidence of major bleeding
Time Frame: At 12 months
Incidence of major bleeding
At 12 months
Incidence of drug discontinuation
Time Frame: At 24 months
Incidence of drug discontinuation
At 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione per la Ricerca Ospedale Maggiore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Luigi Fiocca, MD, ASST Papa Giovanni XXIII

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 21, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 12, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AD-HOC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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