Clopidogrel effect and genetic differences in liver enzymes in stroke patients

Phase 1

Conditions: Ischemic stroke
MedDRA version: 18.0Level: LLTClassification code 10055221Term: Ischemic strokeSystem Organ Class: 100000004852
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2015-003548-38-DK

Lead Sponsor: Roskilde Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Ischemic stroke patients
Treatment with Clopidogrel 75 mg/day
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 83

Exclusion Criteria

treatment with other antiplatelet drug
known cancer disease
Pregnancy or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Is there a connection between single nucleotide polymorphisms of liver enzyme CYP2C19 and the high on treatment platelet reactivity (HOTPR) when treating with Clopidogrel (Clopidogrel-respons) in different doses.;Secondary Objective: Not applicable;Primary end point(s): The conncettion between CYP2C19 genotype and phenotypical clopidogrel respons status measured by VeryfyNow P2Y12.;Timepoint(s) of evaluation of this end point: Clopidogrel response is tested by inclusion and every 5-8 days.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): age, gender, race, Diabetes Mellitus, Tobacco, concomitant medication, previous stroke or acute myocardial infarction, compliance;Timepoint(s) of evaluation of this end point: At end-of study