Clinical trial NCT02556671: Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI
Official title: Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Heart Disease
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-09-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 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, we 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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sunyatsen memorial hospital
Study officials:
affiliation: Sunyatsen memorial hospital
name: ruqiong nie
role: STUDY_CHAIR
References: