Acute Coronary SyndromeTIFUNCT02765711
Ticagrelor in Fuwai Hospital
An observational study of Acute Coronary Syndrome, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial summary
This is a single-arm non-interventional cohort study. This study is to describe the contemporary use of ticagrelor in a "real-world" setting, to reflect its acceptance and patients' compliance, and to observe its one-year safety in patients with acute coronary syndrome in Fuwai Hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- May 2016to May 2018
- 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: This study will include more than 1200 ACS patients using ticagrelor in Fuwai hospital from May 2016 to May 2017.
Who may be able to join
- ≧18 years
- Established diagnosis of acute coronary syndrome
- The use of ticagrelor in hospital
- agree to join this clinical trial and sign informed consent
Who cannot join
- Life-expectancy <1 year
- Dialysis required
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fuwai Hospital
Beijing, Beijing Municipality, 100000
Hongbing Yan, MD, +8610-88322287, yanhongbingsuifang@163.com
Juan Liu, MD, +8610-88322287, tifuliu@163.com
About this study
Official title: TIFU: A Non-Interventional, Descriptive Cohort Study to Describe the Use of Ticagrelor in Patients With Acute Coronary Syndrome (TIFU: Ticagrelor in Fuwai Hospital)
This is a single-arm non-interventional cohort study. This study is to describe the contemporary use of ticagrelor in a "real-world" setting, to reflect its acceptance and patients' compliance, and to observe its one-year safety in patients with acute coronary syndrome in Fuwai Hospital.
- Conditions
- Acute Coronary Syndrome
- Keywords
- ticagrelor, 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 |
|---|---|---|
| the use of ticagrelor in hospital | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with switching between clopidogrel and ticagrelor
Measured: 12 months
Number of participants with switching between clopidogrel and ticagrelor without a reloading dose
Measured: 12 months
Number of Participants with discontinuation of P2Y12 receptor antagonist
Measured: 12 months
Number of Participants with ticagrelor combined with other anticoagulants
Measured: 12 months
Secondary outcomes (2)
Cardiovascular Mortality, Myocardial Infarction(MI), Ischemic Stoke
composite incidence
Myocardial infarction is defined and subclassified in accordance with ACC/AHA/ESC third universal definition of myocardial infarction
Ischemic stroke: an acute episode of focal cerebral, spinal, or retinal dysfunction caused by infarction, defined by at least one of the following:
- Pathological, imaging, or other objective evidence of acute, focal cerebral, spinal, or retinal ischemic injury in a defined vascular distribution
- Symptoms of acute cerebral, spinal, or retinal ischemic injury persisting ≧24 h, with other etiologies excluded
Hemorrhage may be a consequence of ischemic stroke. In this situation, the stroke is an ischemic stroke with hemorrhagic transformation and not a hemorrhagic stroke.
Measured: 12 months
Number of bleeding event will be recorded (defined in accordance with PLATO definition)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2016 (estimated)
- Study startMay 2016
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
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 Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Hongbing Yan, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Hongbing Yan, MD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765711
- Sponsor's protocol ID
- 2016-ZX07
- Other IDs
- ESR-15-11199
- Acronym
- TIFU
- Status last verified
- Jul 2016
- First submitted
- 24 Apr 2016
- Last updated
- 2 Aug 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TIFU: A Non-Interventional, Descriptive Cohort Study to Describe the Use of Ticagrelor in Patients With Acute Coronary Syndrome (TIFU: Ticagrelor in Fuwai Hospital)
- ClinicalTrials.gov ID
- NCT02765711
- Acronym / sponsor ID
- TIFU / 2016-ZX07
- Conditions
- Acute Coronary Syndrome
- Keywords
- ticagrelor, acute coronary syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- May 2016
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 9 May 2016 (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 is a single-arm non-interventional cohort study. This study is to describe the contemporary use of ticagrelor in a "real-world" setting, to reflect its acceptance and patients' compliance, and to observe its one-year safety in patients with acute coronary syndrome in Fuwai Hospital.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| the use of ticagrelor in hospital | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will include more than 1200 ACS patients using ticagrelor in Fuwai hospital from May 2016 to May 2017.
Key inclusion criteria (4 listed)
- ≧18 years
- Established diagnosis of acute coronary syndrome
- The use of ticagrelor in hospital
- agree to join this clinical trial and sign informed consent
Key exclusion criteria (2 listed)
- Life-expectancy <1 year
- Dialysis required
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
Number of participants with switching between clopidogrel and ticagrelor
Time frame: 12 months
Number of participants with switching between clopidogrel and ticagrelor without a reloading dose
Time frame: 12 months
Number of Participants with discontinuation of P2Y12 receptor antagonist
Time frame: 12 months
Number of Participants with ticagrelor combined with other anticoagulants
Time frame: 12 months
2 secondary outcomes
Cardiovascular Mortality, Myocardial Infarction(MI), Ischemic Stoke
Time frame: 12 months
Number of bleeding event will be recorded (defined in accordance with PLATO definition)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2016.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Hongbing Yan, MD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 2 Aug 2016. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbing Yan, MD (+8610-88322287, yanhongbingsuifang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with switching between clopidogrel and ticagrelor (time frame: 12 months). The study lists 4 primary outcomes in all. 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 2 Aug 2016; AzTrials last refreshed its copy on 6 Nov 2026.