NCT03679858

Brief Summary

To search for simple laboratory methods selecting patients with low/non-responsiveness to P2Y12 receptor antagonists.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

January 1, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 20, 2018

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

September 24, 2018

Status Verified

September 1, 2018

Enrollment Period

9 months

First QC Date

September 18, 2018

Last Update Submit

September 20, 2018

Conditions

Cerebrovascular DisordersPlatelet RefractorinessPlatelet Aggregation, Spontaneous

Outcome Measures

Primary Outcomes (1)

  • Major cerebrovascular event

    1 year

Study Arms (2)

Platelet function test in patients

Platelet function test in patients on antiplatelet therapy

Other: Platelet function test

Platelet function test in healthy

Platelet function test in healthy subjects

Other: Platelet function test

Interventions

Platelet function testOTHER

Ex vivo platelet aggregation analysis by Multiplate aggregometer

Platelet function test in healthyPlatelet function test in patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with cerebrovascular disorders on antiplatelet therapy as a secundary prevention.

You may qualify if:

  • Written informed consent

You may not qualify if:

  • Declined informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pécs

Pécs, Baranya, 7624, Hungary

RECRUITING

Related Links

MeSH Terms

Conditions

Cerebrovascular DisordersPlatelet Aggregation, Spontaneous

Interventions

Platelet Function Tests

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic TestsClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Tihamer Molnar, MD, PhD

    University of Pécs Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tihamer Molnar, MD, PhD

CONTACT

+36302275814tihamermolnar@yahoo.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

September 18, 2018

First Posted

September 20, 2018

Study Start

January 1, 2018

Primary Completion

October 1, 2018

Study Completion

January 1, 2019

Last Updated

September 24, 2018

Record last verified: 2018-09

Locations

HU(1)