NCT03203980

Brief Summary

The optimal antithrombotic therapy for patients requiring anticoagulation after coronary stenting is unknown. Double platelets suppressive agents combined with oral anticoagulation (triple antithrombotic therapy) remains the Gold standard. Our study aims at studying bleeding events occurring until 6 months after the initiation of triple antithrombotic therapy.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

June 28, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2017

Completed
16 days until next milestone

Study Start

First participant enrolled

July 15, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2018

Completed
Last Updated

July 11, 2017

Status Verified

June 1, 2017

Enrollment Period

6 months

First QC Date

June 28, 2017

Last Update Submit

July 6, 2017

Conditions

Bleeding

Outcome Measures

Primary Outcomes (1)

  • Bleeding events

    Bleeding events with clinical significance

    within 6 months since the initiation of triple antithrombotic therapy

Interventions

Triple antithrombotic therapyOTHER

patients who are prescribed double antiplatelets agents and oral anticoagulation (except VKA)

Eligibility Criteria

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

Patients from the cardiology care unit of Nancy Central Hospital, hospitalised for coronary stenting and requiring oral anticoagulation (except VKA)

You may qualify if:

  • patients requiring triple antithrombotic therapy, including double antiplatelets agents and oral anticoagulation

You may not qualify if:

  • history of bleeding
  • patients already under triple antithrombotic therapy
  • patients under vitamin K antagonists

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2017

First Posted

June 29, 2017

Study Start

July 15, 2017

Primary Completion

January 15, 2018

Study Completion

July 15, 2018

Last Updated

July 11, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share