Effect of Haemodialysis on the Efficacy of Antiplatelet Agents

NCT ID: NCT03330223

Last Updated: 2018-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-10

Study Completion Date

2019-09-01

Brief Summary

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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.

Detailed Description

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Conditions

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Renal Failure Coronary Artery Disease Hemolysis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Clopidogrel

clopidogrel 75mg qd;aspirin 100mg qd, n=30

Clopidogrel group;Ticagrelor group

Intervention Type DEVICE

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.

Ticagrelor

ticagrelor 90mg bid; aspirin 100mg qd, n=30

Clopidogrel group;Ticagrelor group

Intervention Type DEVICE

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.

Interventions

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Clopidogrel group;Ticagrelor group

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Fuming Zhang, M.D.

Role: primary

+86-25-83718836 ext. 6360

Yi Chai, M.D.

Role: backup

+86-25-83718836 ext. 6360

References

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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.

Reference Type DERIVED
PMID: 38393676 (View on PubMed)

Other Identifiers

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008

Identifier Type: -

Identifier Source: org_study_id

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