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NCT02556671 Clinical Trial

Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI

Coronary Heart Disease Clinical Trial

Official title:
Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT02556671
Other study ID # SunYatsenU2H
Secondary ID
Status Unknown status
Phase N/A
First received August 27, 2015
Last updated September 19, 2015
Start date April 2015
Est. completion date December 2015

Study information
Verified date September 2015
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact ruqiong nie
Phone 860013600479016
Email nieruqiong@126.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.

Recruitment information / eligibility
Status Unknown status
Enrollment 200
Est. completion date December 2015
Est. primary completion date October 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

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.

Exclusion Criteria:

1. Conditions that alter platelet function.

2. Conditions that increase bleeding risk.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Sunyatsen memorial hospital Guangzhou

Sponsors (1)
Lead Sponsor Collaborator
Ruqiong Nie

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 up to 6 months
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