Acute Coronary SyndromeAD-HOCNCT03129867
ADHerence of ticagrelOr in Real World Patients With aCute Coronary Syndrome
An observational study of Acute Coronary Syndrome, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Ticagrelor
- How many people
- 480 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive adult patients discharged from the hospital with a diagnosis of ACS and on ticagrelor therapy
Who may be able to join
- 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
Who cannot join
- Patients taking part in a study with a medical device or experimental drug
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Ticagrelor
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TicagrelorDrug
Also called Brilique
Ticagrelor 60mg or 90 mg as routine use of each Center
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At 12 months
Secondary outcomes (3)
Incidence of major adverse cardiac events (MACE)
Incidence of major adverse cardiac events (MACE)
Measured: At 12 months
Incidence of major bleeding
Incidence of major bleeding
Measured: At 12 months
Incidence of drug discontinuation
Incidence of drug discontinuation
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start1 Jan 2017
- Primary completion31 Mar 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luigi Fiocca, MD, Principal investigator, ASST Papa Giovanni XXIII
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03129867
- Sponsor's protocol ID
- AD-HOC
- Acronym
- AD-HOC
- Status last verified
- Jan 2023
- First submitted
- 21 Apr 2017
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Models of Ticagrelor Discontinuation in Patients With Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03129867
- Acronym / sponsor ID
- AD-HOC / AD-HOC
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Mar 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 26 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive adult patients discharged from the hospital with a diagnosis of ACS and on ticagrelor therapy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients taking part in a study with a medical device or experimental drug
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TicagrelorAlso: BriliqueTicagrelor 60mg or 90 mg as routine use of each Center | Drug | – |
Primary outcome
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
3 secondary outcomes
Incidence of major adverse cardiac events (MACE)
Time frame: At 12 months
Incidence of major bleeding
Time frame: At 12 months
Incidence of drug discontinuation
Time frame: At 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luigi Fiocca, MD principal investigator
ASST Papa Giovanni XXIII
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of drug discontinuation (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023.