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Bleeding Events After Triple Antithrombotic Therapy Initiation. (HEMOTRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03203980
Recruitment Status : Not yet recruiting
First Posted : June 29, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Central Hospital, Nancy, France

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.

Condition or disease Intervention/treatment
Bleeding Other: Triple antithrombotic therapy

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bleeding Events After Triple Antithrombotic Therapy Initiation: a Prospective Observational Study in Real Life
Estimated Study Start Date : July 15, 2017
Estimated Primary Completion Date : January 15, 2018
Estimated Study Completion Date : July 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Intervention Details:
  • Other: Triple antithrombotic therapy
    patients who are prescribed double antiplatelets agents and oral anticoagulation (except VKA)

Primary Outcome Measures :
  1. Bleeding events [ Time Frame: within 6 months since the initiation of triple antithrombotic therapy ]
    Bleeding events with clinical significance

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

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

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Responsible Party: Central Hospital, Nancy, France Identifier: NCT03203980     History of Changes
Other Study ID Numbers: 2017-A01733-50
First Posted: June 29, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pathologic Processes