Canadian Ticagrelor Survey | NCT01757483

Studies
Canadian Ticagrelor Survey

NCT01757483

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 9, 2015Estimated

Enrollment

244Actual

Phase

Not provided

Conditions

Acute Coronary Syndrome

Interventions

Not provided

Countries

Canada

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

Dec 2015

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

Nov 2012

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Dec 18, 2012

First Submission Date that Met QC Criteria

Dec 21, 2012

First Posted Date

Dec 31, 2012Estimated

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

Dec 8, 2015

Last Update Posted Date

Dec 9, 2015Estimated

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

This study is designed to evaluate the effectiveness of the current ticagrelor risk minimisation strategy in Canada through a prescriber knowledge and understanding (KAU) survey of selected important identified safety concerns (i.e., bleeding, dyspnea and drug interactions) and ASA dosage.

Detailed Description

Effectiveness of risk minimisation interventions for ticagrelor in Canada

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

244Actual

Label	Type	Description	Intervention Names
Prescribers

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
KAU Questionnaire: Knowledge of the 4 key safety issues pertaining to ticagrelor (adequate or inadequate for each safety issue)		2 months

Secondary Outcomes

Measure	Description	Time Frame
KAU Questionnaire: Practice characteristics		2 months
KAU Questionnaire: The difference in knowledge of understanding across the key safety concerns		2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- N/A (All prescribers will be contacted for participation)

Exclusion Criteria:

- Participation in a previous wave of the survey.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

All physicians who have prescribed at least one dose of ticargrelor and complete the Knowledge and understanding survey

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yola Moride, PhD	Université de Montréal	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Montreal	Quebec		Canada

Label	URL
CSR Synopsis	View source

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