Dose-Dependent Effect of Early Antiplatelet Therapy in Ac... | NCT01273935

Studies
Dose-Dependent Effect of Early Antiplatelet Therapy in Acute Ischemic Stroke

NCT01273935

Sponsor

Ruhr University of Bochum

Status

Completed

Last Update Posted

Jan 11, 2011Estimated

Enrollment

400Actual

Phase

Not provided

Conditions

Test the Efficacy of Antiplatelet Regimes in Acute Stroke

Interventions

Not provided

Countries

Germany

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

Jan 2010

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 2010

Primary Completion Date

Not provided

Completion Date

Dec 2010Actual

First Submitted Date

Jan 10, 2011

First Submission Date that Met QC Criteria

Jan 10, 2011

First Posted Date

Jan 11, 2011Estimated

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

Jan 10, 2011

Last Update Posted Date

Jan 11, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

The aim of this study is to evaluate the low-response prevalence of early antiplatelet therapy and to test the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Detailed Description

Antiplatelet agents are important therapeutic options in treating patients with acute ischemic strokes to prevent recurrent ischemic events or death. The aim of this study was to evaluate the low-response prevalence of early antiplatelet therapy and the influence of different aspirin dosages in patients with acute ischemic strokes (AIS).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

400Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Responder		Responder versus Non-Responder as a result of platelet function test
Non-Responder		According to the result of platelet function test

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Result of platelet function test	Aggregometry result of antiplatelet therapy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

suspected acute cerebrovascular ischemic events and patients who were admitted to the stroke unit where antiplatelet therapy was initiated

Exclusion Criteria:

severe liver disorders, current gastrointestinal disorders, congestive heart failure, life-threatening malignancies and a personal or family history of bleeding disorders

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

Patients admitted to the stroke unit

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saskia H Meves, MD	Department of Neurology, St. Josef - Hospital, Bochum, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Neurology, St. Josef - Hospital, Ruhr-University		Bochum	North Rhine-Westphalia	D-44791	Germany