Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke) (NATIS)

October 12, 2016 updated by: Zealand University Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Determination of frequency of Clopidigrel- and Acetacylicacid-non-responders (HOTPR) in acute ischemic stroke patients using the VerifyNow system.

Study Type

Observational

Enrollment (Actual)

496

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Neurologisk afdeling

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Acute Ischemic stroke patients

Description

Inclusion Criteria:

  • Suspected acute ischemic stroke and loading dose of Clopidogrel or Acetacylicacid

Exclusion Criteria:

  • Previous treatment with platelet inhibitor
  • NOAC or Vitamin K-antagonist treatment
  • Final diagnosis other than Ischemoc stroke or Transitoric ischemic attack

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Clopidogrel
Clopidogrel non-responders (HOTPR) Blood sampling for HOTPR-testing
Other: blood sampling for HOTPR-testing
All subjects are tested for responderstatus using the VerifyNow System
Acetacylicacid
Acetcylicacid non-responders (HOTPR), Blood sampling for HOTPR-testing
Other: blood sampling for HOTPR-testing
All subjects are tested for responderstatus using the VerifyNow System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Responder status
Time Frame: immediately
Platelet reactivity with PRU measurement
immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Investigators

  • Principal Investigator: Charlotte Rath, MD, Zealand University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

November 16, 2015

First Submitted That Met QC Criteria

November 17, 2015

First Posted (Estimate)

November 18, 2015

Study Record Updates

Last Update Posted (Estimate)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-390

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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