Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy and Mean Precise-DAPT and DAPT Scores in Turkey

Coronary Artery Disease (CAD) is leading cause of death worldwide. Most of them underwent coronary angiography and they have to use dual anti-platelet therapy. As mentioned novel guidelines for CAD, the estimated number of patients requiring dual anti-platelet therapy has increased over time, and DAPT time is controversial. Acting on the behalf of 2017 ESC focused update on dual anti-platelet therapy in coronary artery disease developed in collaboration with EACTS guideline, this study is amid to determine PRECISE-DAPT score which predicts out of hospital bleeding risk in patients receiving dual anti-platelet treatment and to detect the prevalence of patients with high bleeding risk, and to determine DAPT score which predicts benefit/risk ratio of continuing or discontinuing dual ant-iplatelet therapy after 12 months and to detect the prevalence of patients with high ischemic or hemorrhagic complication risk in centers included in this study.

Study Overview

Detailed Description

Design

The study is a national, multicenter, non-interventional, observational, prospective registry.

Population

Patients older than 18 years old of age, have acute coronary syndrome or percutaneous coronary intervention electively and with available admission hemoglobin, white blood cell and creatine clearance data will be enrolled for Precise-DAPT,and Patients older than 18 years old of age and completed 12 months of dual anti-platelet therapy without having hemorrhage and ischemic coronary event and with available data of age, history of smoking, presence of diabetes mellitus, history of percutaneous coronary intervention, paclitaxel eluting stent, stent diameter, history of myocardial infarction, saphenous vein graft intervention, ejection fraction or presence of heart failure. Patients that do not approve informed consent will be excluded.

Aim

This study is amid to investigate the demographic and clinical profile of patients with CAD and on dual anti-platelet therapy, mean precise -DAPT and DAPT scores of Turkey.

Study Type

Observational

Enrollment (Actual)

963

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Balikesir, Turkey
        • Balikesir University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy

Description

Inclusion Criteria:

  • Patients that have acute coronary syndrome or percutaneous coronary intervention electively and with available admission heamoglobin, white blood cell and creatine clearance data and on dual antiplatelet therapy

Exclusion Criteria:

  • Being under eighteen years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ischemia
Time Frame: 3 months
ischemic events of patients on dual antiplatelet therapy
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2018

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

March 27, 2018

First Submitted That Met QC Criteria

July 17, 2018

First Posted (Actual)

July 26, 2018

Study Record Updates

Last Update Posted (Actual)

May 7, 2019

Last Update Submitted That Met QC Criteria

May 6, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • DAPT-TR

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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