Acute Coronary SyndromeNCT01757483
Canadian Ticagrelor Survey
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in Canada.
Trial summary
This study is designed to evaluate the effectiveness of the current ticagrelor risk minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug interactions) and ASA dosage. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 244 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2014
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All physicians who have prescribed at least one dose of ticargrelor and complete the Knowledge and understanding survey
Who may be able to join
- N/A (All prescribers will be contacted for participation)
Who cannot join
- Participation in a previous wave of the survey.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Risk Minimisation Interventions for Ticagrelor in Canada
This study is designed to evaluate the effectiveness of the current ticagrelor risk minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug interactions) and ASA dosage.
Read the detailed description
Effectiveness of risk minimisation interventions for ticagrelor in Canada
- Conditions
- Acute Coronary Syndrome
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Prescribers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
KAU Questionnaire: Knowledge of the 4 key safety issues pertaining to ticagrelor (adequate or inadequate for each safety issue)
Measured: 2 months
Secondary outcomes (3)
KAU Questionnaire: Practice characteristics
Measured: 2 months
KAU Questionnaire: The difference in knowledge of understanding across the key safety concerns
Measured: 2 months
KAU Questionnaire: Association between prescribers' characteristics and knowledge and understanding of the key safety concerns.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014
- Study completionDec 2014
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.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- 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
- Time perspective
- Cross-sectional
- Enrolment
- 244 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yola Moride, PhD, Principal investigator, Université de Montréal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01757483
- Sponsor's protocol ID
- D5130L00009
- Status last verified
- Dec 2015
- First submitted
- 18 Dec 2012
- Last updated
- 9 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Risk Minimisation Interventions for Ticagrelor in Canada
- ClinicalTrials.gov ID
- NCT01757483
- Acronym / sponsor ID
- D5130L00009
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 244 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 31 Dec 2012 (estimated)
- 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.
This study is designed to evaluate the effectiveness of the current ticagrelor risk minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug interactions) and ASA dosage.
Detailed description
Effectiveness of risk minimisation interventions for ticagrelor in Canada
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prescribers | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All physicians who have prescribed at least one dose of ticargrelor and complete the Knowledge and understanding survey
Key inclusion criteria (1 listed)
- N/A (All prescribers will be contacted for participation)
Key exclusion criteria (1 listed)
- Participation in a previous wave of the survey.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
KAU Questionnaire: Knowledge of the 4 key safety issues pertaining to ticagrelor (adequate or inadequate for each safety issue)
Time frame: 2 months
3 secondary outcomes
KAU Questionnaire: Practice characteristics
Time frame: 2 months
KAU Questionnaire: The difference in knowledge of understanding across the key safety concerns
Time frame: 2 months
KAU Questionnaire: Association between prescribers' characteristics and knowledge and understanding of the key safety concerns.
Time frame: 2 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 9 Dec 2015.
- CSR SynopsisLink provided by the sponsor.
Related trials for Acute Coronary Syndrome
Active, not recruiting
Safety and Clinical Performance of the Freesolve Resorbable Magnesium Scaffold System in the Treatment of Subjects With Long de Novo Lesions
Coronary Artery Disease, Atherosclerosis of Coronary Artery
Active, not recruiting
Interventional Strategy for Non-culprit Lesions With Major Vulnerability Criteria at OCT in Patients With ACS
Coronary Artery Disease, Coronary Disease
Active, not recruiting
Point-of-Care Troponin Testing in the Emergency Department
Acute Coronary Syndromes
Enrolling by invitationObservational study
Prevalence of CYP2C19 Genetic Polymorphisms Among Egyptian Patients Receiving Clopidogrel Following PCI
Acute Coronary Syndrome
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
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.
Yola Moride, PhD principal investigator
Université de Montréal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by AstraZeneca at 1 site in Canada.
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 1 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 9 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
KAU Questionnaire: Knowledge of the 4 key safety issues pertaining to ticagrelor (adequate or inadequate for each safety issue) (time frame: 2 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 9 Dec 2015.