Ticagrelor in Fuwai Hospital (TIFU)

July 31, 2016 updated by: Hongbing Yan, Chinese Academy of Medical Sciences, Fuwai Hospital

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

This study will include more than 1200 ACS patients using ticagrelor in Fuwai hospital from May 2016 to May 2017.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
the use of ticagrelor in hospital

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants with switching between clopidogrel and ticagrelor
Time Frame: 12 months
12 months
Number of participants with switching between clopidogrel and ticagrelor without a reloading dose
Time Frame: 12 months
12 months
Number of Participants with discontinuation of P2Y12 receptor antagonist
Time Frame: 12 months
12 months
Number of Participants with ticagrelor combined with other anticoagulants
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cardiovascular Mortality, Myocardial Infarction(MI), Ischemic Stoke
Time Frame: 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:

  1. Pathological, imaging, or other objective evidence of acute, focal cerebral, spinal, or retinal ischemic injury in a defined vascular distribution
  2. 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
Number of bleeding event will be recorded (defined in accordance with PLATO definition)
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital

Collaborators

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

April 24, 2016

First Submitted That Met QC Criteria

May 6, 2016

First Posted (Estimate)

May 9, 2016

Study Record Updates

Last Update Posted (Estimate)

August 2, 2016

Last Update Submitted That Met QC Criteria

July 31, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-ZX07
  • ESR-15-11199 (Other Identifier: AstraZeneca)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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