NCT01271101

Brief Summary

The primary objective of the EASY-CHINA Registry is to describe the clinical epidemiology of Chinese patients with NSTE-ACS, to evaluate their current anticoagulation management in China, and the resources used for it.

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
1,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2010

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

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

January 6, 2011

Status Verified

July 1, 2010

Enrollment Period

8 months

First QC Date

January 5, 2011

Last Update Submit

January 5, 2011

Conditions

Acute Coronary Syndrome

Keywords

Non-ST-elevated acute coronary syndromes (NSTE-ACS)anticoagulation

Outcome Measures

Primary Outcomes (1)

  • the composite of death, MI, refractory ischemia, or stroke and the major bleeding

    9 days

Secondary Outcomes (1)

  • the composite of death, MI, refractory ischemia, or stroke

    30 days

Study Arms (1)

anticoagulant

Eligibility Criteria

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Chinese patients with non-ST-elevated acute coronary syndrome

You may qualify if:

  • with symptoms of UA or MI without persistent ST elevation and at least 1 of the following additional criterias: 1)troponin T or I or CK-MB above the upper limit of normal,2)electrocardiogram (ECG) changes compatible with ischemia (ie, ST depression at least 1mm in 2 contiguous leads or T-wave inversion \>3 mm),3)any dynamic ST shift or transient ST elevation
  • Must be willing to signed informed consent
  • age from 21-80 years
  • without pregnancy or under contraception

You may not qualify if:

  • age\<20 or \>80 years
  • any contraindication to anticoagulant
  • hemorrhagic stroke within 12 months
  • indication for anticoagulation other than ACS
  • prior enrollment in anticoagulants trials in ACS
  • revascularization procedure performed for the qualifying event in one month
  • severe renal insufficiency (ie,serum creatinine\>=3 mg/dL or 265umol/L)
  • pregnancy or breast-feeding women
  • life expectancy\<6 months
  • enrollment in other medicine trials in 3 months
  • with mental illness or uncooperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Public Health, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Jinming Yu, Doctor

    School of Public Health，Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 6, 2011

Study Start

July 1, 2010

Primary Completion

March 1, 2011

Study Completion

August 1, 2011

Last Updated

January 6, 2011

Record last verified: 2010-07

Locations

CN(1)