Renal FailureNCT03330223
Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
An observational study of Renal Failure and Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
The main purpose of our study is to investigate whether haemodialysis itself affects the efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Renal Failure, Coronary Artery Disease, Hemolysis
- What is being tested?
- Clopidogrel group;Ticagrelor group
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Nov 2017to 1 Sep 2019
- 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: Cardiovascular events account for about 50% of all-cause mortality in patients with end-stage renal disease(ESRD), and about 20% of cardiac death events are caused by acute coronary syndromes(ACS).Over the past decade, the number of percutaneous coronary intervention (PCI) in patients with ESRD has increased by nearly 50%. Aspirin, clopidogrel and ticagrelor are the most widely used antiplatelet agents in ACS patients after PCI.Little is known about whether hemodialysis can affect the efficacy of antiplatelet agents or not.
Who may be able to join
- diagnosis of coronary heart disease including stable angina, unstable angina, acute myocardial infarction
- taking dual antiplatelet drugs (clopidogrel 75mg qd + aspirin 100mg qd or ticagrelor 90 mg,bid + aspirin 100 mg,qd) at least 5 days
- haemodialysis patients
- sign informed consent
Who cannot join
- platelet count>450 × 10 9 /L or <100 × 10 9 /L
- using IIb / IIIa inhibitor drugs within 10days
- taking nonsteroidal anti-inflammatory drugs other than aspirin
- hemorrhagic disease
- allergic to aspirin, ticagrelor or clopidogrel
- other factors may affect the results of this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210029
Fuming Zhang, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
Yi Chai, M.D., +86-25-83718836 ext. 6360, jsphkj@163.com
About this study
The main purpose of our study is to investigate whether haemodialysis itself affects the efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after two times of haemodialysis.
- Conditions
- Renal Failure, Coronary Artery Disease, Hemolysis
- Being tested
- Clopidogrel group;Ticagrelor group
- Medical subject headings
- Renal Insufficiency, Coronary Artery Disease, Hemolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clopidogrel group;Ticagrelor groupDevice
A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after haemodialysis.
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | clopidogrel 75mg qd;aspirin 100mg qd, n=30 Receives: Device: Clopidogrel group;Ticagrelor group | |
| Ticagrelor | ticagrelor 90mg bid; aspirin 100mg qd, n=30 Receives: Device: Clopidogrel group;Ticagrelor group |
What is being measured
The primary outcome is the main question the study is designed to answer.
using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents
intravenous blood collection with anticoagulant tube before and after haemodialysis respectively ；using light transmittance aggregometer to detect adenosine diphosphate induced platelet aggregation rate and arachidonic acid induced platelet aggregation rate within two hours after blood collection;;compare the outcome of light transmittance aggregometer with VerifyNow
Measured: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
Secondary outcomes (1)
using VerifyNow to detect whether haemodialysis can affect the efficacy of antiplatelet agents
intravenous blood collection with VeryfiNow to detect the platelet reaction unit before and after haemodialysis respectively
Measured: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start10 Nov 2017
- Primary completion20 Apr 2019 (estimated)
- Study completion1 Sep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical 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
- 60 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330223
- Sponsor's protocol ID
- 008
- Status last verified
- Sep 2017
- First submitted
- 27 Sep 2017
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ye Z, Wang Q, Ullah I, Lin Q, Wu T, Yang M, Fan Y, Dong Z, Wang T, Teng J, Hua R, Tang Y, Li Y, Gong X, Yuan L, Tao Z, Li C. Impact of hemodialysis on efficacies of the antiplatelet agents in coronary artery disease patients complicated with end-stage renal disease. J Thromb Thrombolysis. 2024 Apr;57(4):558-565. doi: 10.1007/s11239-023-02924-5. Epub 2024 Feb 23.
PubMed 38393676
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Haemodialysis on the Efficacy of Antiplatelet Agents
- ClinicalTrials.gov ID
- NCT03330223
- Acronym / sponsor ID
- 008
- Conditions
- Renal Failure, Coronary Artery Disease, Hemolysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 10 Nov 2017 (actual)
- Primary completion
- 20 Apr 2019 (estimated)
- Study completion
- 1 Sep 2019 (estimated)
- First posted
- 6 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.
The main purpose of our study is to investigate whether haemodialysis itself affects the efficacy of antiplatelet drugs and the effects of two different types of dialysis membranes (polysulfone membranes and polyamide membranes) on antiplatelet efficacy. A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after two times of haemodialysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | – | Device: Clopidogrel group;Ticagrelor groupclopidogrel 75mg qd;aspirin 100mg qd, n=30 |
| Ticagrelor | – | Device: Clopidogrel group;Ticagrelor groupticagrelor 90mg bid; aspirin 100mg qd, n=30 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Cardiovascular events account for about 50% of all-cause mortality in patients with end-stage renal disease(ESRD), and about 20% of cardiac death events are caused by acute coronary syndromes(ACS).Over the past decade, the number of percutaneous coronary intervention (PCI) in patients with ESRD has increased by nearly 50%. Aspirin, clopidogrel and ticagrelor are the most widely used antiplatelet agents in ACS patients after PCI.Little is known about whether hemodialysis can affect the efficacy of antiplatelet agents or not.
Key inclusion criteria (4 listed)
- diagnosis of coronary heart disease including stable angina, unstable angina, acute myocardial infarction
- taking dual antiplatelet drugs (clopidogrel 75mg qd + aspirin 100mg qd or ticagrelor 90 mg,bid + aspirin 100 mg,qd) at least 5 days
- haemodialysis patients
- sign informed consent
Key exclusion criteria (6 listed)
- platelet count>450 × 10 9 /L or <100 × 10 9 /L
- using IIb / IIIa inhibitor drugs within 10days
- taking nonsteroidal anti-inflammatory drugs other than aspirin
- hemorrhagic disease
- allergic to aspirin, ticagrelor or clopidogrel
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 |
|---|---|---|
| Clopidogrel group;Ticagrelor groupA total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after haemodialysis. | Device | Clopidogrel, Ticagrelor |
Primary outcome
using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents
Time frame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
intravenous blood collection with anticoagulant tube before and after haemodialysis respectively ；using light transmittance aggregometer to detect adenosine diphosphate induced platelet aggregation rate and arachidonic acid induced platelet aggregation rate within two hours after blood collection;;compare the outcome of light transmittance aggregometer with VerifyNow
1 secondary outcome
using VerifyNow to detect whether haemodialysis can affect the efficacy of antiplatelet agents
Time frame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Derived from this study: PubMed 38393676Ye Z, Wang Q, Ullah I, Lin Q, Wu T, Yang M, Fan Y, Dong Z, Wang T, Teng J, Hua R, Tang Y, Li Y, Gong X, Yuan L, Tao Z, Li C. Impact of hemodialysis on efficacies of the antiplatelet agents in coronary artery disease patients complicated with end-stage renal disease. J Thromb Thrombolysis. 2024 Apr;57(4):558-565. doi: 10.1007/s11239-023-02924-5. Epub 2024 Feb 23.
- Individual participant dataSharing planned: Undecided
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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.
First Affiliated Hospital of Nanjing Medical University
Nanjing, China
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 Renal Failure and Coronary Artery Disease, run by The First Affiliated Hospital with Nanjing Medical 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 6 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 8 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
using light transmittance aggregometer to detect whether haemodialysis can affect the efficacy of antiplatelet agents (time frame: collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours). 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 NCT03330223, which also lists 1 linked publication.
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 8 Jan 2018.