Complex Decisions Regarding Antithrombotic Therapy: the Q... | NCT07486154

Studies
Complex Decisions Regarding Antithrombotic Therapy: the QUIET Study

NCT07486154

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Status

Not yet recruiting

Last Update Posted

Mar 20, 2026Actual

Enrollment

300Estimated

Phase

Not provided

Conditions

Palliative Care

Interventions

Not provided

Countries

Italy

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

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Apr 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Mar 17, 2026

First Submission Date that Met QC Criteria

Mar 17, 2026

First Posted Date

Mar 20, 2026Actual

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

Mar 17, 2026

Last Update Posted Date

Mar 20, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pola Roberto, Prof., Fondazione Policlinico Universitario Agostino Gemelli IRCCSPrincipal Investigator

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCSOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

"Complex decisions regarding antithrombotic therapy: the QUIET study" is a monocentric observational study without drug intervention, conducted through the administration of a questionnaire (survey).The aim of this study is to explore, through the administration of a questionnaire (survey) consisting of hypothetical clinical cases, the approach of physicians regarding the prescription, continuation, or discontinuation of antithrombotic therapies in patients referred to Palliative Care.

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

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence of discontinue/continue antithrombotic therapy	Calculation of the prevalence of physicians who would discontinue or continue antithrombotic therapy when evaluating different clinical scenarios presented to them through a survey.	at enrollment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Affiliation, as a physician, with one of the main Italian scientific societies actively involved in the management of antithrombotic therapy in patients referred to Palliative Care
Electronic informed consent to participate in the study.

Exclusion Criteria:

Failure to complete or incomplete completion of the questionnaire.

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Physicians affiliated with Italian scientific societies (SICP, SIMI, SIGG, SISET, SIAPAV) and involved in the management of antithrombotic therapy in patients referred to Palliative Care.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Roberto Pola	Contact	+390630157075		roberto.pola@policlinicogemelli.it
Rosa Talerico	Contact	+390630157075		rosa.talerico@unicatt.it

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Fondazione Policlinico Universitario Agostino Gemelli IRCCS		Rome		00168	Italy

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided