Coronary Heart DiseaseNCT02888652
Study on the Registration of Coronary Heart Disease Patients Undergoing PCI
An observational study of Coronary Heart Disease, run by The Third Xiangya Hospital of Central South University at 1 site in China.
Trial summary
Study on the registration of coronary heart disease patients undergoing PCI in Chinese's population. Get the incidence of adverse events in these patients after PCI, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Heart Disease
- What is being tested?
- antiplatelet agents(Clopidogrel or Ticagrelor)
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- Sep 2015to Oct 2018
- How long will I take part?
- 1 Year
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.
Who may be able to join
- Chinese's patients diagnosed with coronary heart disease and accept stent implantation.
- Accept aspirin and P2Y12 receptor inhibitors (clopidogrel or ticagrelorwere）after stent implantation.
- Willingness and ability to sign informed consent.
- Can communicate effectively and complete the trial.
Who cannot join
- Occurrence of a major complication during the procedure of percutaneous coronary intervention or before platelet function testing.
- Allergy or intolerance to aspirin or P2Y12 receptor inhibitors (Clopidogrel or Ticagrelor）
Trial locations and contacts
1 site in 1 country.
China1 site
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
About this study
Official title: Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI
Study on the registration of coronary heart disease patients undergoing PCI in Chinese's population. Get the incidence of adverse events in these patients after PCI, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and provide the basis for further research and reference.
Read the detailed description
Dual antiplatelet therapy, comprising a low-dose aspirin and a kind of P2Y12 Receptor Inhibitors, has been the mainstay of the management in patients with acute coronary syndromes and/or undergoing Percutaneous Coronary Intervention (PCI). While variability to P2Y12 receptor inhibitors is common in patients and is a major cause of adverse cardiovascular events. Low response to P2Y12 receptor inhibitors will result high platelet reactivity (HPR) and patients who exhibit HPR are at increased risk of atherothrombotic occlusion events. Vice versa, high response to P2Y12 receptor inhibitors will lead to low platelet reactivity (LPR) and increase the risk of hemorrhage.Now, the absence of a universal definition of therapeutic window for different racial and actual clinical situations and lacking the gold standard test to quantify it limit the use in clinic practice.So this clinical trial try to use patient's platelet reactivity combine with type of adverse reaction, forms, influencing factors to find a proper therapeutic windows for P2Y12 receptor inhibitors in Chinese people.
- Conditions
- Coronary Heart Disease
- Being tested
- antiplatelet agents(Clopidogrel or Ticagrelor)
- Keywords
- Coronary Heart Disease, PCI, Anti-Platelet Agents
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antiplatelet agents(Clopidogrel or Ticagrelor)Drug
Also called Clopidogrel or Ticagrelor
Clinical physicians according to patients condition to give different antiplatelet agents(Clopidogrel or Ticagrelor).We only observe clinical curative effect.
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiovascular events
ischemic and bleeding
Measured: within 1 year after PCI
Secondary outcomes (3)
Blood drug concentration
Clopidogrel and Ticagrelor
Measured: at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents
Mild to moderate adverse events
renal function
Measured: within 1 year after PCI
Platelet activity
Platelet activity
Measured: at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Third Xiangya Hospital of Central South 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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,500 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GuoPing Yang, professor, Principal investigator, The Third Xiangya Hospital of Central South UniversityYu Cao, MD, Principal investigator, The Third Xiangya Hospital of Central South UniversityJingle Li, MD, Principal investigator, The Third Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02888652
- Sponsor's protocol ID
- XY3-CLOP1507A01
- Other IDs
- ChiCTR-OOC-16009006
- Status last verified
- Oct 2019
- First submitted
- 11 Aug 2016
- Last updated
- 14 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multivariate Analysis of Platelet Reactivity Variety in Patients With Coronary Heart Disease After PCI
- ClinicalTrials.gov ID
- NCT02888652
- Acronym / sponsor ID
- XY3-CLOP1507A01
- Conditions
- Coronary Heart Disease
- Keywords
- Coronary Heart Disease, PCI, Anti-Platelet Agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,500 participants (actual)
- Lead sponsor
- The Third Xiangya Hospital of Central South UniversityUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 5 Sep 2016 (estimated)
- 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.
Study on the registration of coronary heart disease patients undergoing PCI in Chinese's population. Get the incidence of adverse events in these patients after PCI, a clear type of adverse reaction, forms, influencing factors, to establish risk management processes, clinical safety and reasonable treatment, and provide the basis for further research and reference.
Detailed description
Dual antiplatelet therapy, comprising a low-dose aspirin and a kind of P2Y12 Receptor Inhibitors, has been the mainstay of the management in patients with acute coronary syndromes and/or undergoing Percutaneous Coronary Intervention (PCI). While variability to P2Y12 receptor inhibitors is common in patients and is a major cause of adverse cardiovascular events. Low response to P2Y12 receptor inhibitors will result high platelet reactivity (HPR) and patients who exhibit HPR are at increased risk of atherothrombotic occlusion events. Vice versa, high response to P2Y12 receptor inhibitors will lead to low platelet reactivity (LPR) and increase the risk of hemorrhage.Now, the absence of a universal definition of therapeutic window for different racial and actual clinical situations and lacking the gold standard test to quantify it limit the use in clinic practice.So this clinical trial try to use patient's platelet reactivity combine with type of adverse reaction, forms, influencing factors to find a proper therapeutic windows for P2Y12 receptor inhibitors in Chinese people.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with coronary artery disease treated with aspirin and clopidogrel after successful stent implantation.
Key inclusion criteria (4 listed)
- Chinese's patients diagnosed with coronary heart disease and accept stent implantation.
- Accept aspirin and P2Y12 receptor inhibitors (clopidogrel or ticagrelorwere）after stent implantation.
- Willingness and ability to sign informed consent.
- Can communicate effectively and complete the trial.
Key exclusion criteria (2 listed)
- Occurrence of a major complication during the procedure of percutaneous coronary intervention or before platelet function testing.
- Allergy or intolerance to aspirin or P2Y12 receptor inhibitors (Clopidogrel or Ticagrelor）
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| antiplatelet agents(Clopidogrel or Ticagrelor)Also: Clopidogrel or TicagrelorClinical physicians according to patients condition to give different antiplatelet agents(Clopidogrel or Ticagrelor).We only observe clinical curative effect. | Drug | – |
Primary outcome
Major adverse cardiovascular events
Time frame: within 1 year after PCI
ischemic and bleeding
3 secondary outcomes
Blood drug concentration
Time frame: at 5-7 days, 1month, 3 months, 6 months and 12 months after taking anti-platelet agents
Mild to moderate adverse events
Time frame: within 1 year after PCI
Platelet activity
Time frame: at 12- 24 hours, 1 month, 3 months, 6 months and 12 months after PCI
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2019.
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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.
GuoPing Yang, professor principal investigator
The Third Xiangya Hospital of Central South University
Yu Cao, MD principal investigator
The Third Xiangya Hospital of Central South University
Jingle Li, MD principal investigator
The Third Xiangya Hospital of Central South University
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 Coronary Heart Disease, run by The Third Xiangya Hospital of Central South 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 4 inclusion and 2 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 14 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Major adverse cardiovascular events (time frame: within 1 year after PCI). 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 14 Oct 2019.