NCT03444012

Brief Summary

noninterventional study investigating persistence and adherence on ticagrelor in ACS patients in Serbia

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
269

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

March 5, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2019

Completed
Last Updated

August 7, 2020

Status Verified

July 1, 2020

Enrollment Period

1.4 years

First QC Date

February 9, 2018

Last Update Submit

August 5, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • duration (number of days) on ticagrelor therapy in patients with acute coronary syndrome

    1 year (12 months)

Interventions

persistence and adherence on ticagrelor in ACS patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult ACS patients

You may qualify if:

  • ≥ 18 years of age
  • diagnosed with ACS - STEMI or NSTEMI or unstable angina, invasively or non-invasively treated
  • Patients already on treatment with ticagrelor at least for 1 month and no longer than 3 months prior to study initiation. Enrolment in this study must not be trigger for ticagrelor initiation.
  • read and signed the Informed Consent Form

You may not qualify if:

  • Any contraindications as per approved SmPC of Brilique
  • Patients with life-threatening conditions which could disable patients to comply with scheduled visits and/or not able to fill in the patient questionnaires.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

CHC Bezanijska Kosa

Belgrade, Serbia

Location

CHC Zemun

Belgrade, Serbia

Location

CHC Zvezdara

Belgrade, Serbia

Location

Clinical Center of Serbia

Belgrade, Serbia

Location

Institute for cardiovascular diseases, Dedinje

Belgrade, Serbia

Location

Medical Military Academy

Belgrade, Serbia

Location

Institute for cardiovascular diseases of Vojvodina

Kamenitz, Serbia

Location

Clinical Center Kragujevac

Kragujevac, Serbia

Location

Clinical Center Nis

Niš, Serbia

Location

Related Links

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Ticagrelor

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosides

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2018

First Posted

February 23, 2018

Study Start

March 5, 2018

Primary Completion

August 13, 2019

Study Completion

August 13, 2019

Last Updated

August 7, 2020

Record last verified: 2020-07

Locations