NCT02607358

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
496

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

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

January 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 16, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

October 13, 2016

Status Verified

October 1, 2016

Enrollment Period

1.6 years

First QC Date

November 16, 2015

Last Update Submit

October 12, 2016

Conditions

Acute Ischemic Stroke

Keywords

Clopidogrelacetacylic acidantiplatelet therapyHOTPRVerifyNow

Outcome Measures

Primary Outcomes (1)

  • Responder status

    Platelet reactivity with PRU measurement

    immediately

Study Arms (2)

Clopidogrel

Clopidogrel non-responders (HOTPR) Blood sampling for HOTPR-testing

Other: blood sampling for HOTPR-testing

Acetacylicacid

Acetcylicacid non-responders (HOTPR), Blood sampling for HOTPR-testing

Other: blood sampling for HOTPR-testing

Interventions

blood sampling for HOTPR-testingOTHER

All subjects are tested for responderstatus using the VerifyNow System

AcetacylicacidClopidogrel

Eligibility Criteria

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

Acute Ischemic stroke patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurologisk afdeling

Roskilde, 4000, Denmark

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Charlotte Rath, MD

    Zealand University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2015

First Posted

November 18, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

October 13, 2016

Record last verified: 2016-10

Locations

DK(1)