Coronary Heart DiseaseNCT02556671
Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI
An observational study of Coronary Heart Disease, run by Ruqiong Nie at 1 site in China.
Trial summary
Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However, inhibition of platelet activation and aggregation after DAPT varies greatly among patients. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Heart Disease
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Apr 2015to Dec 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However, inhibition of platelet activation and aggregation after In these studies, platelet function was only assessed by a single measurement and a single method early after the start of antiplatelet treatment. To test the stability of platelet reactivity measurements over time among patients undergoing PCI, we use 3 methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days), with maintenance doses of clopidogrel.
Who may be able to join
- 1. >18 years old.
- 2.15 ≤ eGFR < 60 ml/min/1.73 m2.
- 3. Clinically stable and following PCI between 4 weeks and 1 year.
- 4. On clopidogrel (75mg/d) and aspirin (100mg/d) treatment at least 4 weeks.
Who cannot join
- Conditions that alter platelet function.
- Conditions that increase bleeding risk.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sunyatsen memorial hospital
Guangzhou
Ruqiong Nie, 860013600479016
About this study
Official title: Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention
Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However, inhibition of platelet activation and aggregation after DAPT varies greatly among patients. Some clinical studies have demonstrated that patients with high on-treatment platelet reactivity are at increased risk of major adverse cardiovascular events. Tailored antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting by drug adjustment based on platelet function testing. Unfortunately, the results of 3 major prospective trials (GRAVITAS, ARCTIC, TRIGGER PCI) of personalized antiplatelet therapy are neutral. In these studies, platelet function was only assessed by a single measurement and a single method early after the start of antiplatelet treatment. To test the stability of platelet reactivity measurements over time among patients undergoing PCI, investigators use 3 methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days), with maintenance doses of clopidogrel.
- Conditions
- Coronary Heart Disease
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Moderate CKD Patients Undergoing PCI | Not described | |
| Normal renal function Patients Undergoing PCI | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Individual Platelet Reactivity Measured by VerifyNow P2Y12 Assay Over Time after Receiving Clopidogrel among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention -- A Cross-Sectional Study
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
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.
- 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruqiong Nie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruqiong Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- ruqiong nie, Study chair, Sunyatsen memorial hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556671
- Sponsor's protocol ID
- SunYatsenU2H
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2015
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT02556671
- Acronym / sponsor ID
- SunYatsenU2H
- Conditions
- Coronary Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ruqiong NieUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 22 Sep 2015 (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.
Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However, inhibition of platelet activation and aggregation after DAPT varies greatly among patients. Some clinical studies have demonstrated that patients with high on-treatment platelet reactivity are at increased risk of major adverse cardiovascular events. Tailored antiplatelet therapy seems offer an opportunity to improve outcomes after coronary stenting by drug adjustment based on platelet function testing. Unfortunately, the results of 3 major prospective trials (GRAVITAS, ARCTIC, TRIGGER PCI) of personalized antiplatelet therapy are neutral. In these studies, platelet function was only assessed by a single measurement and a single method early after the start of antiplatelet treatment. To test the stability of platelet reactivity measurements over time among patients undergoing PCI, investigators use 3 methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days), with maintenance doses of clopidogrel.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moderate CKD Patients Undergoing PCI | – | – |
| Normal renal function Patients Undergoing PCI | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dual antiplatelet therapy (DAPT) with standard doses of aspirin and clopidogrel has long been the cornerstone in patients undergoing percutaneous coronary intervention (PCI). However, inhibition of platelet activation and aggregation after In these studies, platelet function was only assessed by a single measurement and a single method early after the start of antiplatelet treatment. To test the stability of platelet reactivity measurements over time among patients undergoing PCI, we use 3 methods (VerifyNow P2Y12 assay, Flow cytometric assessment of the phosphorylation status of VASP, light transmittance aggregometry) for platelet function testing in 2 periods (~14days), with maintenance doses of clopidogrel.
Key inclusion criteria (4 listed)
- 1. >18 years old.
- 2.15 ≤ eGFR < 60 ml/min/1.73 m2.
- 3. Clinically stable and following PCI between 4 weeks and 1 year.
- 4. On clopidogrel (75mg/d) and aspirin (100mg/d) treatment at least 4 weeks.
Key exclusion criteria (2 listed)
- Conditions that alter platelet function.
- Conditions that increase bleeding risk.
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
Change in Individual Platelet Reactivity Measured by VerifyNow P2Y12 Assay Over Time after Receiving Clopidogrel among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention -- A Cross-Sectional Study
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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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.
ruqiong nie study chair
Sunyatsen memorial 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 Coronary Heart Disease, run by Ruqiong Nie 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: status not confirmed, as of the sponsor's last update on 22 Sep 2015. 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 ruqiong nie (860013600479016, nieruqiong@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Individual Platelet Reactivity Measured by VerifyNow P2Y12 Assay Over Time after Receiving Clopidogrel among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention -- A Cross-Sectional Study (time frame: up to 6 months). 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 22 Sep 2015.