Clopidogrel effect and genetic differences in liver enzymes in stroke patients

CLOpidogrel response and CYP2C19 Genotype in Ischemic Stroke patients

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003548-38-DK

Enrollment

Unknown

Registered

2015-08-12

Start date

2015-09-29

Completion date

Unknown

Last updated

2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic stroke MedDRA version: 18.0 Level: LLT Classification code 10055221 Term: Ischemic stroke System Organ Class: 100000004852

Interventions

Trade Name: Clopidogrel Product Name: Clopidogrel Pharmaceutical Form: Tablet INN or Proposed INN: Clopidogrel Other descriptive name: CLOPIDOGREL Concentration unit: mg milligram(s) Concentration typ

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: treatment with other antiplatelet drug known cancer disease Pregnancy or breastfeeding

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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	—

Countries

Denmark

Contacts

Public ContactNeurologisk Afdeling, Roskilde Syge

Neurologisk Afdeling, Roskilde Sygehus

+4547322800

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026