TIFU: Ticagrelor in Fuwai Hospital

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02765711

Collaborator

AstraZeneca (Industry)

1,200

Enrollment

Location

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Acute Coronary Syndrome

Study Design

Study Type:

Observational

Anticipated Enrollment :

1200 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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)

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

May 1, 2018

Anticipated Study Completion Date :

May 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
the use of ticagrelor in hospital

Outcome Measures

Primary Outcome Measures

Number of participants with switching between clopidogrel and ticagrelor [12 months]
Number of participants with switching between clopidogrel and ticagrelor without a reloading dose [12 months]
Number of Participants with discontinuation of P2Y12 receptor antagonist [12 months]
Number of Participants with ticagrelor combined with other anticoagulants [12 months]

Secondary Outcome Measures

Cardiovascular Mortality, Myocardial Infarction(MI), Ischemic Stoke [12 months]
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.
Number of bleeding event will be recorded (defined in accordance with PLATO definition) [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

≧18 years
Established diagnosis of acute coronary syndrome
The use of ticagrelor in hospital
agree to join this clinical trial and sign informed consent

Exclusion Criteria:

Life-expectancy <1 year
Dialysis required

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing	Beijing	China	100000

Sponsors and Collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital
AstraZeneca

Investigators

Principal Investigator: Hongbing Yan, MD, Chinese Academy of Medical Sciences, Fuwai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hongbing Yan, The deputy director of Center of Coronary Heart Disease and Center of Chest Pain, Chinese Academy of Medical Sciences, Fuwai Hospital

ClinicalTrials.gov Identifier:

NCT02765711

Other Study ID Numbers:

2016-ZX07
ESR-15-11199

First Posted:

May 9, 2016

Last Update Posted:

Aug 2, 2016

Last Verified:

Jul 1, 2016

Keywords provided by Hongbing Yan, The deputy director of Center of Coronary Heart Disease and Center of Chest Pain, Chinese Academy of Medical Sciences, Fuwai Hospital

ticagrelor

acute coronary syndrome

Additional relevant MeSH terms:

Acute Coronary Syndrome

Syndrome

Study Results

No Results Posted as of Aug 2, 2016