MedTrace Logo

ADHerence of ticagrelOr in Real World Patients With aCute Coronary Syndrome

NCT03129867 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 480

Last updated 2023-01-12

No results posted yet for this study

Summary

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.

Conditions

  • Acute Coronary Syndrome

Interventions

DRUG

Ticagrelor

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

Sponsors & Collaborators

  • FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

    lead OTHER

Principal Investigators

  • Luigi Fiocca, MD · ASST Papa Giovanni XXIII

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-01
Primary Completion
2020-03-31
Completion
2020-12-31
FDA Drug
Yes

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03129867 on ClinicalTrials.gov