NCT02093299

Brief Summary

Stroke patients are given prophylactic treatment with clopidogrel to prevent new strokes. Some of these patients (the investigators don't know precisely how many, but previous studies indicate 4-34%) are so called non-responders, when you measure on a blood sample from the patient. These patients may have an increased risk for less effect of the treatment and therefore a higher risk for a new stroke. The investigators want to investigate if clopidogrel non-responders have a clinically increased risk of a new stroke by following the patients for two years. With this study the investigators aim to ensure that all patients get the best prophylactic treatment and reduce the risk of early death and dependency of others.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2016

Completed
Last Updated

July 2, 2017

Status Verified

June 1, 2017

Enrollment Period

4 years

First QC Date

March 19, 2014

Last Update Submit

June 28, 2017

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Number of patient with new stroke

    2 years

Secondary Outcomes (1)

  • Number of patients with transitory ischemic attack

    2 years

Study Arms (1)

Stroke

clopidogrel 75 mg

Drug: Clopidogrel

Interventions

ClopidogrelDRUG

a blood sample is drawn on all patients to determine responder status

Also known as: non-responders, VeryfyNow
Stroke

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

First time stroke patients

You may qualify if:

  • Patients admitted to neurological department with stroke signs om CT or MRI or history consistent with stroke and gives clopidogrel 75 mg as prophylactic treatment.

You may not qualify if:

  • cancer diagnosis Other anti platelet treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurologisk afdeling

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Stroke

Interventions

Clopidogrel

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Charlotte Rath, MD

    Dept. of Neurology Roskilde University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 20, 2014

Study Start

December 1, 2012

Primary Completion

November 22, 2016

Study Completion

November 22, 2016

Last Updated

July 2, 2017

Record last verified: 2017-06

Locations

DK(1)