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Completed

NCT Number: NCT03129867

ADHerence of ticagrelOr in Real World 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.

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Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ticagrelor

Drug

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

Other names: Brilique

Primary outcomes

  1. 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

Secondary outcomes

  1. Incidence of major adverse cardiac events (MACE)

    Time frame: At 12 months

    Incidence of major adverse cardiac events (MACE)

  2. Incidence of major bleeding

    Time frame: At 12 months

    Incidence of major bleeding

  3. Incidence of drug discontinuation

    Time frame: At 24 months

    Incidence of drug discontinuation

Sponsors and collaborators

Lead sponsor

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS

Other

Registry information

Official study title

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

Acronym: AD-HOC

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 26, 2017
Registry last updated
Jan 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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