Non-responders to Antiplatelet Treatment in Acute Ischaem... | NCT02607358

Studies
Non-responders to Antiplatelet Treatment in Acute Ischaemic Stroke)

NCT02607358

Sponsor

Zealand University Hospital

Status

Completed

Last Update Posted

Oct 13, 2016Estimated

Enrollment

496Actual

Phase

Not provided

Conditions

Acute Ischemic Stroke

Interventions

blood sampling for HOTPR-testing

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2015

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Nov 16, 2015

First Submission Date that Met QC Criteria

Nov 17, 2015

First Posted Date

Nov 18, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 12, 2016

Last Update Posted Date

Oct 13, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

496Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
blood sampling for HOTPR-testing	Other	All subjects are tested for responderstatus using the VerifyNow System	Acetacylicacid Clopidogrel

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute Ischemic stroke patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte Rath, MD	Zealand University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Neurologisk afdeling		Roskilde		4000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided