- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03758248
The Influence of Gene Polymorphism on Clinical Outcomes in Patients Undergoing PCI
December 4, 2020 updated by: Yujie Zhou, Beijing Anzhen Hospital
Dual antiplatelet therapy with aspirin and thienopyridines is an essential treatment in patients undergoing percutaneous coronary intervention (PCI).
However, despite intensified antiplatelet treatment, some of the patients undergoing PCI develop thrombotic stent occlusion, suggesting incomplete platelet inhibition due to thienopyridine resistance.
Some patients develop bleeding event because of the improper dosage and covariation.
This observational study is designed for clarifying the Influence of gene polymorphism on clinical outcomes in patients undergoing PCI.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Patients undergoing PCI who received dual antiplatelet therapy with both aspirin (100mg) and P2Y12 inhibitors in standard dosage were enrolled.
Investigators examined plasma biomarkers for platelet activation and DNA in those patients, and then analyzed the CYP2C19 genetic polymorphism to examine the influence of this genetic variation on the several biomarkers for platelet activation and bleeding event.
Study Type
Observational
Enrollment (Anticipated)
12000
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
-
-
Beijing
-
Beijing, Beijing, China, 100029
- Recruiting
- Beijing Anzhen Hospital
-
Contact:
- Yujie Zhou, MD, PhD
- Phone Number: 8613901330652
- Email: azzyj12@163.com
-
Contact:
- Yujing Cheng, MD
- Phone Number: 8613426481193
- Email: 13426481193@163.com
-
Principal Investigator:
- Yujie Zhou, MD, PhD
-
-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
PCI patients in Beijing Anzhen Hospital from August 2018 to August 2019
Description
Inclusion Criteria:
- The patients undergoing PCI
- More than 18 years old
- Treated with aspirin and P2Y12 inhibitors (clopidogrel or ticagrelor)
Exclusion Criteria:
Inability to provide written informed consent
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients with treatment-related major bleeding event as assessed by the Bleeding Academic Research Consortium (BARC) bleeding criteria
Time Frame: up to 24 months
|
The major bleeding event was a composite endpoint of BARC bleeding type 3 and 5), defined according to the BARC bleeding criteria, which was used widely in this field.
BARC bleeding was defined as follows: BARC type 1, any bleeding that is not actionable; type 2, any overt, actionable sign of bleeding; type 3a, overt bleeding with a haemoglobin drop of 3-5 g/dL or any transfusion; type 3b, overt bleeding with a haemoglobin drop >5 g/dL, requiring vasopressors, surgical intervention, or due to cardiac tamponade; type 3c, any intracranial or intraocular bleeding; and finally type 5, any bleeding resulting in death (type 4 was coronary artery bypass graft-related bleeding, which was excluded).
Investigator will get all the information through regular return visit and telephone follow-up after discharge.
|
up to 24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major adverse cardiac events (MACE)
Time Frame: up to 24 months
|
A composite of death, myocardial infarction, stroke, stent thrombosis, and ischemia-driven revascularization
|
up to 24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Yujie Zhou, PhD,MD, Beijing Anzhen 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 (Actual)
December 1, 2018
Primary Completion (Anticipated)
August 31, 2021
Study Completion (Anticipated)
September 30, 2021
Study Registration Dates
First Submitted
November 15, 2018
First Submitted That Met QC Criteria
November 28, 2018
First Posted (Actual)
November 29, 2018
Study Record Updates
Last Update Posted (Actual)
December 8, 2020
Last Update Submitted That Met QC Criteria
December 4, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- gene polymorphism
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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