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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03330223
Other study ID # 008
Secondary ID
Status Recruiting
Phase N/A
First received September 27, 2017
Last updated January 4, 2018
Start date November 10, 2017
Est. completion date September 1, 2019

Study information

Verified date September 2017
Source The First Affiliated Hospital with Nanjing Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date September 1, 2019
Est. primary completion date April 20, 2019
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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

Study Design


Intervention

Device:
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.

Locations

Country Name City State
China First Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu

Sponsors (1)

Lead Sponsor Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
Secondary 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 collecting blood within 10 miuntes before and after haemodialysis;detecting them within 2 hours
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