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Genetic Polymorphism Contributing to the Variability of Clopidogrel Response in Patients With Coronary Artery Disease

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ClinicalTrials.gov Identifier: NCT03373552
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Chouchene Saoussen, Hôpital Universitaire Fattouma Bourguiba

Brief Summary:
Clopidogrel non-responsiveness is probably multifactorial; several genetic and non genetic factors may contribute to impaired platelet inhibition by clopidogrel. In this regard, it is meaningful to determine genetic polymorphisms contributing to the variability of clopidogrel response in patients with Coronary Artery Disease (CAD). In fact, the recognition of these factors might predict the exposure to the risk of thrombosis and cardiovascular death in these patients. Therefore, the goal of this study is to determine the impact of the polymorphisms, affecting CYP2C19, ABCB1, PON1 and P2RY12 genes, on the response to clopidogrel in patients with CAD.

Condition or disease Intervention/treatment
Clopidogrel Diagnostic Test: Platelet function assay

Detailed Description:

In an observational study with cross-sectional analysis and prospective data collection, the investigators recruit patients with:

  • >20 years old
  • An established coronary artery disease defined by an episode of ST‐elevation myocardial infarction, non‐ST‐elevation acute coronary syndrome or stable angina
  • An exposure to clopidogrel therapy (75 mg per day for at least 7 consecutive days).

The exclusion criteria are:

  • Presence of allergy to clopidogrel
  • Severe hepatic dysfunction, disease or active pathological bleeding (e.g., gastrointestinal (GI) bleeding)
  • Use of glycoprotein IIb/IIIa inhibitors or cilostazol
  • inability to give informed consent.

Collected data for patients encompasse baseline characteristics, including age, gender, obesity (defined as a body mass index ≥30 kg/m2), smoking, medical history, and coadministered drugs.

The study protocol was approved by the Ethics Committee for Clinical Research at our center and all subjects gave informed consent for study participation.

Platelet function assay is assessed by the VerifyNow P2Y12 analyzer following manufacturer instructions (Accumetrics, Inc. San Diego, CA, USA) using venous blood samples collected in tube containing 3.2% sodium citrate.

Genotyping for CYP2C19, ABCB1, PON1 and P2RY12 polymorphism is performed using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) and sequencing.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 3 Years
Official Title: Determination of Genetic Polymorphisms Contributing to the Variability of Clopidogrel Response in Patients With Coronary Artery Disease
Actual Study Start Date : August 12, 2015
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
non responder Group

Platelet function assay:

High platelet reactivity: PRU>230

Diagnostic Test: Platelet function assay
Platelet function assay

responder Group

Platelet function assay:

PRU<230

Diagnostic Test: Platelet function assay
Platelet function assay




Primary Outcome Measures :
  1. Platelet reactivity on clopidogrel [ Time Frame: at least after 7 days ]
    Platelet reactivity on clopidogrel is assessed by the VerifyNow P2Y12 assay


Other Outcome Measures:
  1. Genotyping for genetic polymorphisms [ Time Frame: an average of 1 month ]
    Genotyping for genetic polymorphisms is performed using PCR-RFLP and sequencing


Biospecimen Retention:   Samples With DNA
Venous blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with coronary artery disease treated by clopidogrel therapy
Criteria

Inclusion Criteria:

  • Patient >20 years old
  • Established coronary artery disease defined by an episode of ST‐elevation myocardial infarction, non‐ST‐elevation acute coronary syndrome or stable angina
  • Exposure to clopidogrel therapy (75 mg per day for at least 7 consecutive days).

Exclusion Criteria:

  • Presence of allergy to clopidogrel
  • Severe hepatic dysfunction
  • Disease or active pathological bleeding (e.g., gastrointestinal (GI) bleeding)
  • Use of glycoprotein IIb/IIIa inhibitors or cilostazol
  • inability to give informed consent.

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): NCT03373552


Contacts
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Contact: Saoussen chouchene, assistant 216 97772361 saoussen_chouchene@yahoo.fr

Locations
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Tunisia
Fattouma Bourguiba Hospital Recruiting
Monastir, Tunisia, 5000
Contact: saoussen Chouchene, assistant    216 97772361    saoussen_chouchene@yahoo.fr   
Principal Investigator: saoussen chouchene, assistant         
Sponsors and Collaborators
Hôpital Universitaire Fattouma Bourguiba
Investigators
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Principal Investigator: chouchene saoussen, assistant Fattouma Bourguiba Hospital

Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chouchene Saoussen, Professor Assistant in hematology, Hôpital Universitaire Fattouma Bourguiba
ClinicalTrials.gov Identifier: NCT03373552     History of Changes
Other Study ID Numbers: FattoumaBourguiba
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chouchene Saoussen, Hôpital Universitaire Fattouma Bourguiba:
Coronary Artery Disease; Clopidogrel; Polymorphism, genetic

Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs