E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Ischemic stroke |
Iskæmisk apoplexia cerebri |
|
E.1.1.1 | Medical condition in easily understood language |
Stroke |
Blodprop i hjernen |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10055221 |
E.1.2 | Term | Ischemic stroke |
E.1.2 | System Organ Class | 100000004852 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Er der sammenhæng mellem Single Nukleotid Polymorfismer (SNP'er) i genet CYP2C19 ogclopidogrelrespons ved forskellige doser af clopidogrel. |
|
E.2.2 | Secondary objectives of the trial |
Not applicable |
Not applicable |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Ischemic stroke patients Treatment with Clopidogrel 75 mg/day |
Iskæmisk apopleksi Behandling med clopidogrel 75 mg/dag |
|
E.4 | Principal exclusion criteria |
treatment with other antiplatelet drug known cancer disease Pregnancy or breastfeeding
|
• Kendt cancersygdom eller lidelse, der medfører øget blødningsrisiko. • Samtidig behandling med anden trombocythæmmer ud over den første uge af behandling med clopidogrel. • Gravide eller ammende kvinder
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
The conncettion between CYP2C19 genotype and phenotypical clopidogrel respons status measured by VeryfyNow P2Y12. |
Sammenhængen mellem genotypen af CYP2C19 og fænotypisk Clopidogrel responderstatus på VerifyNow p2Y12 måling. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Clopidogrel response is tested by inclusion and every 5-8 days. |
Clopidogrel responderstatus testes ved inklusion og hver 5-8 dag. |
|
E.5.2 | Secondary end point(s) |
age, gender, race, Diabetes Mellitus, Tobacco, concomitant medication, previous stroke or acute myocardial infarction, compliance |
o Alder o Køn o Race o Diabetes Mellitus o Rygerstatus o Anden medicin o Tidligere AMI/apopleksi o compliance
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
At end-of study |
Ved afslutning i studiet |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
LVLS |
Sidste besøg for sidste patient |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |