Brilinta Clinical Experience Investigation | NCT03212287

Status Module

Record Verification Date

Jul 2025

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

Dec 21, 2017Actual

Primary Completion Date

Jul 31, 2024Actual

Completion Date

Jul 31, 2024Actual

First Submitted Date

Jun 19, 2017

First Submission Date that Met QC Criteria

Jul 6, 2017

First Posted Date

Jul 11, 2017Actual

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

Jul 11, 2025

Last Update Posted Date

Jul 16, 2025Actual

Description Module

Brief Summary

To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as "BRILINTA") in clinical practice in the post-marketing phase.

Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc.
Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
Factors which may affect safety or efficacy of ticagrelor

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

663Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Adverse event incidence		from baseline to 4 years
Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI		from baseline to 4 years
Incidence of cardiovascular events		from baseline to 4 years
Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment		from baseline to 4 years
Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment		from baseline to 4 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

130 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Aichi		454-0933	Japan
Research Site

Label	URL
Redacted CSR Synopsis	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.

All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Types

Not provided

Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

URL

https://astrazenecagroup-dt.pharmacm.com/DT/Home

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

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