Stent ThrombosisNCT03491891

Factors Contribute to Very Late Stent Thrombosis After New Generation DES Implantation in China

An observational study of Stent Thrombosis, run by The First Hospital of Jilin University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The investigators sought to identify and verify the potential correlates and mechanisms of Very Late Stent Thrombosis (VLST) after the implantation of new generation drug eluting steng in China from an analysis of multicenter registries. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Stent Thrombosis
How many people: 8,476 participants
Where: 1 siteChina
Study dates: 1 Jan 2014to 1 Jun 2019
How long will I take part?: 5 Years
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent were included.Patients' expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al),and with a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued, refusing to sign informed consent, died prior to discharge, unable to participate in regular follow-up were excluded.

Who may be able to join

Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent.

Who cannot join

Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.

Trial locations and contacts

1 site in 1 country.

China1 site

Jilin University 1st Hospital
Changchun, Jilin, 130021

Other trials in China

About this study

Official title: Correlates and Mehcanisms Underlying Very Late Stent Thrombosis After Implantation of New Generation DES in China

Read the detailed description

This study represents a patient-level pooled analysis of patients undergoing percutaneous coronary intervention with stent implantation for acute coronary syndrome. Multiple aspects including clinical, angiographic, procedural characteristics , intravascular imaging results and blood samples were collected at index PCI and the time of VLST or CAG during follow-up, in order to reveal the potential mechanisms or risk factors that contribute to the development of VLST.

Conditions: Stent Thrombosis
Keywords: Very Late Stent Thrombosis, New generation DES

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03491891
Study group	Role	What they receive
derivation cohort		no interventions will be administrated
validation cohort		no interventions will be administrated

What is being measured

The primary outcome is the main question the study is designed to answer.

Very Late Stent Thrombosis
very late stent thrombosis demonstrated by coronary angiography
Measured: Five years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20141 Jun 2019

First posted9 Apr 2018
Study start1 Jan 2014
Primary completion1 Jun 2015
Study completion1 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stent ThrombosisStudies of the same condition, open and under way.
More trials run by The First Hospital of Jilin UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 8,476 participants (actual)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT03491891
Sponsor's protocol ID: wx19871203
Status last verified: Jun 2018
First submitted: 2 Apr 2018
Last updated: 20 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: When the investigation is completed,we will share it with other researchers.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
RecruitingObservational study
RevCore for In Stent Thrombosis
In-stent Thrombosis
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
Hypertension, Portal, Interventional Radiology

All Stent Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Correlates and Mehcanisms Underlying Very Late Stent Thrombosis After Implantation of New Generation DES in China
ClinicalTrials.gov ID: NCT03491891
Acronym / sponsor ID: wx19871203
Conditions: Stent Thrombosis
Keywords: Very Late Stent Thrombosis, New generation DES
Study type: Observational
Recruitment status: Completed
Enrolment: 8,476 participants (actual)
Lead sponsor: The First Hospital of Jilin UniversityUniversity, hospital or other
Collaborators: First Affiliated Hospital of Shantou University Medical College
Study start: 1 Jan 2014 (actual)
Primary completion: 1 Jun 2015 (actual)
Study completion: 1 Jun 2019 (actual)
First posted: 9 Apr 2018 (actual)
Results: Posted 20 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 5 Years
Number of arms: 2

Arm	Type	Receives
derivation cohort	–	–no interventions will be administrated
validation cohort	–	–no interventions will be administrated

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent were included.Patients' expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al),and with a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued, refusing to sign informed consent, died prior to discharge, unable to participate in regular follow-up were excluded.

Key inclusion criteria (1 listed)

Patients>18y,admitted for acute coronary syndrome,successfully underwent PCI with at least one stent, sign informed consent.

Key exclusion criteria (1 listed)

Expected lifetime was less than 1 year for any severe disease(such as tumor,severe respiratory failure et al). There is a surgical plan for important organs within 1 year after surgery and anti-platelet drugs should be discontinued. Refusing to sign informed consent.Died prior to discharge. Poor compliance, unable to participate in regular follow-up.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Very Late Stent Thrombosis
Time frame: Five years
very late stent thrombosis demonstrated by coronary angiography

Results and safety

Results posted to the registry on 20 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Derivation Cohort	6,038	5,185
Validation Cohort	2,438	2,058

Primary outcome: Very Late Stent Thrombosis

Time frame: Five years. Count of participants. Unit: Participants

Measure	Derivation Cohort n = 5185	Validation Cohort n = 2058
Value	92	35

Adverse events

Time frame: five years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Derivation Cohort	0 of 6,038 (0%)	0 of 6,038 (0%)	316 of 6,038
Validation Cohort	0 of 2,438 (0%)	0 of 2,438 (0%)	132 of 2,438

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. When the investigation is completed,we will share it with other researchers.

Related trials for Stent Thrombosis

Active, not recruiting
Thromboelastography With Platelet Mapping to Guide Antiplatelet Therapy After Lower Extremity Revascularization
Thrombosis, Arterial Occlusive Diseases
RecruitingObservational study
RevCore for In Stent Thrombosis
In-stent Thrombosis
Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Not yet recruitingObservational study
The ReCAna for Lower ExtremIty Venous OBstructions and In-StEnt Restenosis Registry
Chronic Venous Disease, Chronic Venous Insufficiency, CVI
Active, not recruitingObservational study
Percutaneous Portal Vein Recanalization for Refractory Portal Hypertension in Children With Non-Cirrhotic Extrahepatic Portal Vein Obstruction
Hypertension, Portal, Interventional Radiology

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

yang zheng study director

Jilin University 1st Hospital Cardiovascular Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Stent Thrombosis, run by The First Hospital of Jilin University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Very Late Stent Thrombosis (time frame: Five years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03491891.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2019.