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Status unknownNCT03353779Updated Jan 25, 2018

The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients

An observational study in Percutaneous Coronary Intervention and Coronary Artery Disease, sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2018-01-25.

Sponsored by Chinese Academy of Medical Sciences, Fuwai Hospital · Observational

The sponsor has not verified this record recently (last verified Jan 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,440
Sex
All
01

Study 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

Read the detailed description

This study will observe the relationship between platelet function testing and clinical outcomes. Meanwhile we aim to identify optimal cut-off values in different platelet function testing, including IPF, TEG and VerifyNow, to predict MACCE during12-months in complex PCI patients.

02

Conditions studied

  • Percutaneous Coronary Intervention
  • Coronary Artery Disease

Keywords

  • Percutaneous coronary intervention
  • antiplatelet
  • platelet function
  • prognosis
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In context

Coronary Artery Disease

5,676 studies on the registry are indexed under Coronary Artery Disease; 958 are open to participants now.

This study's planned enrollment of 1,440 is above the median of 335 across 1,978 observational studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

Chinese Academy of Medical Sciences, Fuwai Hospital is the lead sponsor of 146 studies on the registry; 50 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,440 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

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

    Time frame: Within 12 months of patient enrolled

Secondary outcomes

  1. Effectiveness and sensitivity of predicting between different platelet function testing

    Time frame: Within 12 months of patient enrolled

07

Study locations

1 of 1 sites recruiting
  • Chinese Academy of Medical Sciences Fuwai Hospital
    Beijing, Beijing Municipality 100037, China
    • Chunli Shao, MD, PhD · Contact · +861088396171
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03353779
Responsible party
Yi-Da Tang (Professor, Chief Physician, Chinese Academy of Medical Sciences, Fuwai Hospital) — Principal investigator
First posted
Nov 27, 2017
Start date
Nov 29, 2017
Primary completion
Jul 29, 2021 (estimated)
Completion
Jul 29, 2021 (estimated)
Last update
Jan 25, 2018

Study contacts

Chunli Shao, MD
Contact
chunlishao@126.com
+861088396171
Yida Tang, MD, PhD
principal investigator · Chinese Academy of Medical Sciences, Fuwai Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

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