Ticagrelor in Fuwai Hospital

Acute Coronary Syndrome Clinical Trial

— TIFU  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02765711
• Other study ID #: 2016-ZX07
• Secondary ID: ESR-15-11199
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2016
• Last updated: July 31, 2016
• Start date: May 2016
• Est. completion date: May 2018

Study information

• Verified date: July 2016
• Source: Chinese Academy of Medical Sciences, Fuwai Hospital
• Contact: Hongbing Yan, MD
• Phone: +8610-88322287
• Email: yanhongbingsuifang[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. ?18 years

2. Established diagnosis of acute coronary syndrome

3. The use of ticagrelor in hospital

4. agree to join this clinical trial and sign informed consent

Exclusion Criteria:

1. Life-expectancy <1 year

2. Dialysis required

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Syndrome

Locations

Country	Name	City	State
China	Fuwai Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Medical Sciences, Fuwai Hospital	AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with switching between clopidogrel and ticagrelor		12 months	No
Primary	Number of participants with switching between clopidogrel and ticagrelor without a reloading dose		12 months	No
Primary	Number of Participants with discontinuation of P2Y12 receptor antagonist		12 months	No
Primary	Number of Participants with ticagrelor combined with other anticoagulants		12 months	No
Secondary	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.	12 months	No
Secondary	Number of bleeding event will be recorded (defined in accordance with PLATO definition)		12 months	Yes