Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI

• Conditions: Coronary Heart Disease

• Registration Number: NCT02556671
• Lead Sponsor: Ruqiong Nie

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-08-27
• Status Verified: 2015-09
• Study First Submitted QC: 2015-09-19
• Last Update Submitted: 2015-09-19
• Study First Posted: 2015-09-22
• Last Update Posted: 2015-09-22
• Primary Completion: 2015-10
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Sunyatsen memorial hospital; 🇨🇳 Guangzhou, China