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Trial record 89 of 508 for:    ASPIRIN AND P2

Platelet Reactivity After Receiving Clopidogrel Among Moderate CKD Patients Undergoing PCI

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ClinicalTrials.gov Identifier: NCT02556671
Recruitment Status : Unknown
Verified September 2015 by Ruqiong Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University.
Recruitment status was:  Recruiting
First Posted : September 22, 2015
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Ruqiong Nie, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Condition or disease
Coronary Heart Disease

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Platelet Reactivity Over Time After Receiving Clopidogrel Among Moderate CKD Patients Undergoing Percutaneous Coronary Intervention
Study Start Date : April 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Clopidogrel

Group/Cohort
Moderate CKD Patients Undergoing PCI
Normal renal function Patients Undergoing PCI



Primary Outcome Measures :
  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 [ Time Frame: up to 6 months ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02556671


Contacts
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Contact: ruqiong nie 860013600479016 nieruqiong@126.com

Locations
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China
Sunyatsen memorial hospital Recruiting
Guangzhou, China
Contact: Ruqiong Nie    860013600479016      
Sponsors and Collaborators
Ruqiong Nie
Investigators
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Study Chair: ruqiong nie Sunyatsen memorial hospital

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Responsible Party: Ruqiong Nie, director of cardiology, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02556671     History of Changes
Other Study ID Numbers: SunYatsenU2H
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs