ADHerence of ticagrelOr in Real World Patients With aCute Coronary Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

480 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ticagrelor

Ticagrelor 60mg or 90 mg as routine use of each Center

Intervention Type DRUG

Other Intervention Names

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Brilique

Eligibility Criteria

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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