ADHerence of ticagrelOr in Real World Patients With aCute Coronary Syndrome

NCT03129867 | Completed FDA Drug

• 1 other identifier: AD-HOC
• Study Type: observational
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of drug discontinuation

  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 Outcomes (3)

• Incidence of major adverse cardiac events (MACE)

  At 12 months

• Incidence of major bleeding

  At 12 months

• Incidence of drug discontinuation

  At 24 months

Interventions

Ticagrelor DRUG

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

Also known as: Brilique

Eligibility Criteria

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

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Luigi Fiocca, MD

  ASST Papa Giovanni XXIII

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 26, 2017
• Study Start: January 1, 2017
• Primary Completion: March 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share