Percutaneous Coronary InterventionNCT03353779
The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients
An observational study of Percutaneous Coronary Intervention and Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Percutaneous Coronary Intervention, Coronary Artery Disease
- How many people
- 1,440 participants
- Where
- 1 siteChina
- Study dates
- 29 Nov 2017to 29 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Documented undergoing complex PCI in 1 year prior to enrollment.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Fuwai Hospital
Beijing, Beijing Municipality, 100037
Chunli Shao, MD, PhD, +861088396171
About this study
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.
- Keywords
- Percutaneous coronary intervention, antiplatelet, platelet function, prognosis
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China
Measured: Within 12 months of patient enrolled
Secondary outcomes (1)
Effectiveness and sensitivity of predicting between different platelet function testing
Measured: Within 12 months of patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start29 Nov 2017
- Primary completion29 Jul 2021 (estimated)
- Study completion29 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Percutaneous Coronary InterventionStudies of the same condition, open and under way.
- More trials run by Chinese Academy of Medical Sciences, Fuwai HospitalThe 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
- 1,440 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi-Da Tang, Chinese Academy of Medical Sciences, Fuwai Hospital
- Investigators
- Yida Tang, MD, PhD, Principal investigator, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353779
- Sponsor's protocol ID
- 2017-901
- Status last verified
- Jan 2018
- First submitted
- 20 Nov 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact Of Platelet Function on 1-year Outcome in Complex PCI Patients
- ClinicalTrials.gov ID
- NCT03353779
- Acronym / sponsor ID
- 2017-901
- Keywords
- Percutaneous coronary intervention, antiplatelet, platelet function, prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,440 participants (estimated)
- Lead sponsor
- Chinese Academy of Medical Sciences, Fuwai HospitalUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 29 Jul 2021 (estimated)
- Study completion
- 29 Jul 2021 (estimated)
- First posted
- 27 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To identify the optimal cut-off values in different platelet function testing to predict MACCE at 12-months in complex PCI patients of China
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Documented undergoing complex PCI in 1 year prior to enrollment.
Key exclusion criteria (3 listed)
- 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.
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
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
1 secondary outcome
Effectiveness and sensitivity of predicting between different platelet function testing
Time frame: Within 12 months of patient enrolled
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Undecided
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Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
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ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
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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.
Yida Tang, MD, PhD principal investigator
Chinese Academy of Medical Sciences, Fuwai Hospital
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 Percutaneous Coronary Intervention and Coronary Artery Disease, run by Chinese Academy of Medical Sciences, Fuwai Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 25 Jan 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunli Shao, MD (+861088396171, chunlishao@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jan 2018.