Platelet Function in Patients With an Acute Coronary Synd... | NCT01992484

Studies
Platelet Function in Patients With an Acute Coronary Syndrome

NCT01992484

Sponsor

Medical University of Vienna

Status

Unknown status

Last Update Posted

Nov 25, 2013Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Acute Coronary Syndrome (ACS)

Interventions

Not provided

Countries

Austria

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

Nov 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Jun 2015Estimated

Completion Date

Not provided

First Submitted Date

Nov 19, 2013

First Submission Date that Met QC Criteria

Nov 19, 2013

First Posted Date

Nov 25, 2013Estimated

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

Nov 19, 2013

Last Update Posted Date

Nov 25, 2013Estimated

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

The aims of the study are to:

explore whether platelet reactivity in patients treated wih novel platelet inhibitors is associated with clinical outcome
investigate whether a therapeutic window exist for novel platelet inhibitors
investigate the incidence of adverse events under treatment with novel platelet inhibitors in the real life clinical scenario
investigate the association between genetic polymorphisms, inflammation, platelet reactivity and clinical outcome
investigate synergistic effects between aspirin and novel platelet inhibitors

Detailed Description

Not provided

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

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Net clinical benefit.	A composite of MACE and BARC=>2 bleedings.	1 year

Secondary Outcomes

Measure	Description	Time Frame
MACE and Major bleeding	MACE: the composite of stent thrombosis, cardiac death and myocardial infarction. Major Bleeding: BARC =>2, TIMI major, GUSTO moderate-severe-life threatening.	1 year

Other Outcomes

Measure	Description	Time Frame
single endpoints of acute coronary syndrome, myocardial infarction, cardiac death, all-cause death, urgent vessel revascularization (PCI or CABG), stroke.		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed informed consent
Acute coronary syndrome at admission
Planned treatment with novel platelet inhibitors
Age >18

Exclusion Criteria:

* Participation in interventional trials

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 presenting with an acute coronary syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jolanta M Siller-Matula, PD MD PhD	Contact	0043 1 404004614		jolanta.siller-matula@meduniwien.ac.at

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical Univerity of Vienna, Department of Cardiology	Recruiting	Vienna			Austria

Condition Browse Module

MeSH Terms

ID	Term
D054058	Acute Coronary Syndrome

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided