Acute Ischemic StrokeNATISNCT02607358
Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke)
An observational study of Acute Ischemic Stroke, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- blood sampling for HOTPR-testing
- How many people
- 496 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Aug 2016
- 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: Acute Ischemic stroke patients
Who may be able to join
- Suspected acute ischemic stroke and loading dose of Clopidogrel or Acetacylicacid
Who cannot join
- Previous treatment with platelet inhibitor
- NOAC or Vitamin K-antagonist treatment
- Final diagnosis other than Ischemoc stroke or Transitoric ischemic attack
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NATIS: Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke
Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients.
Read the detailed description
Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients using the VerifyNow system.
- Conditions
- Acute Ischemic Stroke
- Being tested
- blood sampling for HOTPR-testing
- Keywords
- Clopidogrel, acetacylic acid, antiplatelet therapy, HOTPR, VerifyNow
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling for HOTPR-testingOther
All subjects are tested for responderstatus using the VerifyNow System
| Study group | Role | What they receive |
|---|---|---|
| Clopidogrel | Clopidogrel non-responders (HOTPR) Blood sampling for HOTPR-testing Receives: Other: blood sampling for HOTPR-testing | |
| Acetacylicacid | Acetcylicacid non-responders (HOTPR), Blood sampling for HOTPR-testing Receives: Other: blood sampling for HOTPR-testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder status
Platelet reactivity with PRU measurement
Measured: immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Rath, MD, Principal investigator, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02607358
- Sponsor's protocol ID
- SJ-390
- Acronym
- NATIS
- Status last verified
- Oct 2016
- First submitted
- 16 Nov 2015
- Last updated
- 13 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NATIS: Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke
- ClinicalTrials.gov ID
- NCT02607358
- Acronym / sponsor ID
- NATIS / SJ-390
- Conditions
- Acute Ischemic Stroke
- Keywords
- Clopidogrel, acetacylic acid, antiplatelet therapy, HOTPR, VerifyNow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 18 Nov 2015 (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.
Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients.
Detailed description
Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients using the VerifyNow system.
Study design
- Observational model
- Cohort
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clopidogrel | – | Other: blood sampling for HOTPR-testingClopidogrel non-responders (HOTPR) Blood sampling for HOTPR-testing |
| Acetacylicacid | – | Other: blood sampling for HOTPR-testingAcetcylicacid non-responders (HOTPR), Blood sampling for HOTPR-testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute Ischemic stroke patients
Key inclusion criteria (1 listed)
- Suspected acute ischemic stroke and loading dose of Clopidogrel or Acetacylicacid
Key exclusion criteria (3 listed)
- Previous treatment with platelet inhibitor
- NOAC or Vitamin K-antagonist treatment
- Final diagnosis other than Ischemoc stroke or Transitoric ischemic attack
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood sampling for HOTPR-testingAll subjects are tested for responderstatus using the VerifyNow System | Other | Acetacylicacid, Clopidogrel |
Primary outcome
Responder status
Time frame: immediately
Platelet reactivity with PRU measurement
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 13 Oct 2016.
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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.
Charlotte Rath, MD principal investigator
Zealand University Hospital
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 Acute Ischemic Stroke, run by Zealand University Hospital at 1 site in Denmark.
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 1 inclusion and 3 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 13 Oct 2016. 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 Denmark. 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?
Responder status (time frame: immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Oct 2016.