Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI

NCT02556671 | Unknown DMC

• 1 other identifier: SunYatsenU2H
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Heart Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Moderate CKD Patients Undergoing PCI

Normal renal function Patients Undergoing PCI

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. \>18 years old.
• ≤ eGFR \< 60 ml/min/1.73 m2.
• \. Clinically stable and following PCI between 4 weeks and 1 year.
• \. On clopidogrel (75mg/d) and aspirin (100mg/d) treatment at least 4 weeks.

You may not qualify if:

• Conditions that alter platelet function.
• Conditions that increase bleeding risk.

Sponsors & Collaborators

• Ruqiong Nie: lead

Study Sites (1)

Sunyatsen memorial hospital

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Coronary Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• ruqiong nie

  Sunyatsen memorial hospital

  STUDY CHAIR

Central Study Contacts

ruqiong nie

CONTACT

860013600479016; nieruqiong@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: director of cardiology

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: September 22, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

CN (1)