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

Sponsor
Hôpital Universitaire Fattouma Bourguiba (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03373552
Collaborator
(none)
150
1
172.6
0.9

Study Details

Study Description

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 Therefore, the goal of this study is to determine the impact of the polymorphisms, affecting CYP2C19, ABCB1, ITGB3 and P2RY12 genes, on the response to clopidogrel in patients with CAD.Disease (CAD). In fact, the recognition of these factors might predict the exposure to the risk of thrombosis and cardiovascular death in these patients.

Condition or Disease Intervention/Treatment Phase
  • 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 10 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, ITGB3 and P2RY12 polymorphism is performed using the polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP) and sequencing.

Study Design

Study Type:
Observational [Patient Registry]
Actual Enrollment :
150 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Determination of Genetic Polymorphisms Contributing to the Variability of Clopidogrel Response in Patients With Coronary Artery Disease
Actual Study Start Date :
Aug 12, 2015
Anticipated Primary Completion Date :
Nov 15, 2029
Anticipated Study Completion Date :
Dec 31, 2029

Arms and Interventions

Arm Intervention/Treatment
non responder Group

Platelet function assay: High platelet reactivity: PRU>208

Diagnostic Test: Platelet function assay
Platelet function assay

responder Group

Platelet function assay: PRU<208

Diagnostic Test: Platelet function assay
Platelet function assay

Outcome Measures

Primary Outcome Measures

  1. Platelet reactivity on clopidogrel [at least after 10 days]

    Platelet reactivity on clopidogrel is assessed by the VerifyNow P2Y12 assay

Other Outcome Measures

  1. Genotyping for genetic polymorphisms [an average of 1 month]

    Genotyping for genetic polymorphisms is performed using PCR-RFLP and sequencing

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 10 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fattouma Bourguiba Hospital Monastir Tunisia 5000

Sponsors and Collaborators

  • Hôpital Universitaire Fattouma Bourguiba

Investigators

  • Principal Investigator: chouchene saoussen, assistant, Fattouma Bourguiba Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Chouchene Saoussen, Professor Assistant in hematology, Hôpital Universitaire Fattouma Bourguiba
ClinicalTrials.gov Identifier:
NCT03373552
Other Study ID Numbers:
  • FattoumaBourguiba
First Posted:
Dec 14, 2017
Last Update Posted:
Sep 17, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Chouchene Saoussen, Professor Assistant in hematology, Hôpital Universitaire Fattouma Bourguiba
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 17, 2021