Bleeding Events After Triple Antithrombotic Therapy Initiation. (HEMOTRI)

Bleeding Events After Triple Antithrombotic Therapy Initiation: a Prospective Observational Study in Real Life

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.

Study Overview

• Status: Unknown
• Conditions: Bleeding
• Intervention / Treatment: Other: Triple antithrombotic therapy

• Study Type: Observational
• Enrollment (Anticipated): 200

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding events	Bleeding events with clinical significance	within 6 months since the initiation of triple antithrombotic therapy

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Anticipated): July 15, 2017
• Primary Completion (Anticipated): January 15, 2018
• Study Completion (Anticipated): July 15, 2018

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 28, 2017
• First Posted (Actual): June 29, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: 2017-A01733-50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No