NCT01843361

Brief Summary

The aim of this study was to determine the prevalence rate and risk factors for chemical laboratory clopidogrel low-response (CLR) in the acute phase after an ischemic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2013

Completed
Last Updated

April 30, 2013

Status Verified

April 1, 2013

Enrollment Period

2.4 years

First QC Date

April 26, 2013

Last Update Submit

April 26, 2013

Conditions

Ischemic Stroke

Keywords

StrokeClopidogrelAggregometryAntiplatelet therapyPlatelet function tests

Outcome Measures

Primary Outcomes (1)

  • Result of platelet function test

    Aggregometry result of antiplatelet therapy

    one day

Study Arms (1)

acute ischemic stroke

Determing cardiovascular risk factors or medication on clopidogrel response rates after an acute ischemic stroke

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with an acute ischemic stroke admitted to our stroke unit and treated with clopidogrel

You may qualify if:

  • acute ischemic stroke
  • admittance to stroke unit
  • clopidogrel medication

You may not qualify if:

  • no consent
  • prior bleeding disorders
  • severe liver disorders
  • current gastrointestinal disorders
  • congestive heart failure
  • life-threatening malignancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Ruhr University Bochum

Bochum, 44791, Germany

Location

Related Publications (2)

  • Meves SH, Overbeck U, Endres HG, Krogias C, Neubauer H. Dose-dependent effect of early antiplatelet therapy in acute ischaemic stroke. Thromb Haemost. 2012 Jan;107(1):69-79. doi: 10.1160/TH11-06-0436. Epub 2011 Dec 8.

    PMID: 22159509BACKGROUND

  • Fong J, Cheng-Ching E, Hussain MS, Katzan I, Gupta R. Predictors of biochemical aspirin and clopidogrel resistance in patients with ischemic stroke. J Stroke Cerebrovasc Dis. 2011 May-Jun;20(3):227-30. doi: 10.1016/j.jstrokecerebrovasdis.2009.12.004. Epub 2010 Jul 10.

    PMID: 20621513BACKGROUND

MeSH Terms

Conditions

Ischemic StrokeStroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Saskia H Meves, MD

    Ruhr University Bochum, Department of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 26, 2013

First Posted

April 30, 2013

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

April 30, 2013

Record last verified: 2013-04

Locations

DE(1)