NCT02765711

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

August 2, 2016

Status Verified

July 1, 2016

Enrollment Period

2 years

First QC Date

April 24, 2016

Last Update Submit

July 31, 2016

Conditions

Acute Coronary Syndrome

Keywords

ticagreloracute coronary syndrome

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • Cardiovascular Mortality, Myocardial Infarction(MI), Ischemic Stoke

    12 months

  • Number of bleeding event will be recorded (defined in accordance with PLATO definition)

    12 months

Study Arms (1)

the use of ticagrelor in hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Life-expectancy \<1 year
  • Dialysis required

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Hongbing Yan, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbing Yan, MD

CONTACT

+8610-88322287yanhongbingsuifang@163.com

Juan Liu, MD

CONTACT

+8610-88322287tifuliu@163.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
The deputy director of Center of Coronary Heart Disease and Center of Chest Pain

Study Record Dates

First Submitted

April 24, 2016

First Posted

May 9, 2016

Study Start

May 1, 2016

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

August 2, 2016

Record last verified: 2016-07

Locations

CN(1)