Ischemic StrokeBo-CRISPNCT01843361
Clopidogrel Response in Acute Ischemic Stroke. The Bochumer CRISP Study
An observational study of Ischemic Stroke, run by Ruhr University of Bochum at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 159 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Dec 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an acute ischemic stroke admitted to our stroke unit and treated with clopidogrel
Who may be able to join
- acute ischemic stroke
- admittance to stroke unit
- clopidogrel medication
Who cannot join
- no consent
- prior bleeding disorders
- severe liver disorders
- current gastrointestinal disorders
- congestive heart failure
- life-threatening malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke.
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.
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Clopidogrel, Aggregometry, Antiplatelet therapy, Platelet function tests
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| acute ischemic stroke | Determing cardiovascular risk factors or medication on clopidogrel response rates after an acute ischemic stroke |
What is being measured
The primary outcome is the main question the study is designed to answer.
Result of platelet function test
Aggregometry result of antiplatelet therapy
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2013 (estimated)
- Study startJul 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia Meves, Ruhr University of Bochum
- Investigators
- Saskia H Meves, MD, Principal investigator, Ruhr University Bochum, Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01843361
- Sponsor's protocol ID
- Meves-clopi-01
- Acronym
- Bo-CRISP
- Status last verified
- Apr 2013
- First submitted
- 26 Apr 2013
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22159509Fong 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.
PubMed 20621513
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Low Response to Clopidogrel in Patients After Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT01843361
- Acronym / sponsor ID
- Bo-CRISP / Meves-clopi-01
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, Clopidogrel, Aggregometry, Antiplatelet therapy, Platelet function tests
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| acute ischemic stroke | – | –Determing cardiovascular risk factors or medication on clopidogrel response rates after an acute ischemic stroke |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an acute ischemic stroke admitted to our stroke unit and treated with clopidogrel
Key inclusion criteria (3 listed)
- acute ischemic stroke
- admittance to stroke unit
- clopidogrel medication
Key exclusion criteria (6 listed)
- no consent
- prior bleeding disorders
- severe liver disorders
- current gastrointestinal disorders
- congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Result of platelet function test
Time frame: one day
Aggregometry result of antiplatelet therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2013.
- Background: PubMed 22159509Meves 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.
- Background: PubMed 20621513Fong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saskia H Meves, MD principal investigator
Ruhr University Bochum, Department of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by Ruhr University of Bochum at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result of platelet function test (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01843361, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2013.