NCT03353779

Brief Summary

To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

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
1,440

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2017

Typical duration for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
2 days until next milestone

Study Start

First participant enrolled

November 29, 2017

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2021

Completed
Last Updated

January 25, 2018

Status Verified

January 1, 2018

Enrollment Period

3.7 years

First QC Date

November 20, 2017

Last Update Submit

January 24, 2018

Conditions

Keywords

Percutaneous coronary interventionantiplateletplatelet functionprognosis

Outcome Measures

Primary Outcomes (1)

  • Optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China

    Within 12 months of patient enrolled

Secondary Outcomes (1)

  • Effectiveness and sensitivity of predicting between different platelet function testing

    Within 12 months of patient enrolled

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with complex PCI were defined as having at least 1of the following features :3 vessels treated,≥3 stents implanted, ≥3 lesions treated,bifurcation with 2stents implanted ,total stent length \>60 mm or chronic total occlusion.

You may qualify if:

  • Documented undergoing complex PCI in 1 year prior to enrollment.

You may not qualify if:

  • Presence of any condition/circumstance which in the opinion of the investigator could significantly limit the complete follow up of the patient (e.g. tourist, non-native speaker or does not understand the local language where interpreter services are not reliably available, psychiatric disturbances, alcohol or drug abuse).
  • Presence of serious/severe co-morbidities in the opinion of the investigator which may limit life expectancy (\<1 year).
  • Current participation in a blinded randomized clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Yida Tang, MD, PhD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunli Shao, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Chief Physician

Study Record Dates

First Submitted

November 20, 2017

First Posted

November 27, 2017

Study Start

November 29, 2017

Primary Completion

July 29, 2021

Study Completion

July 29, 2021

Last Updated

January 25, 2018

Record last verified: 2018-01

Locations