Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI

NCT ID: NCT02556671

Last Updated: 2015-09-22

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-12-31

Brief Summary

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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

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Conditions

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Coronary Heart Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Moderate CKD Patients Undergoing PCI

No interventions assigned to this group

Normal renal function Patients Undergoing PCI

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ruqiong Nie

OTHER

Sponsor Role lead

Responsible Party

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Ruqiong Nie

director of cardiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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ruqiong nie

Role: STUDY_CHAIR

Sunyatsen memorial hospital

Locations

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Sunyatsen memorial hospital

Guangzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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ruqiong nie

Role: CONTACT

860013600479016

Facility Contacts

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Ruqiong Nie

Role: primary

860013600479016

Other Identifiers

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SunYatsenU2H

Identifier Type: -

Identifier Source: org_study_id

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