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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03601013
Other study ID # DAPT-TR
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2018
Est. completion date March 1, 2019

Study information

Verified date May 2019
Source Cardiovascular Academy Society, Turkey
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 963
Est. completion date March 1, 2019
Est. primary completion date November 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Demographical and Clinical Profile of Patients on Dual Antiplatelet Therapy
Demographical and Clinical Profile of Patients on Dual Antiplatelet Therapy

Locations

Country Name City State
Turkey Balikesir University Balikesir

Sponsors (1)

Lead Sponsor Collaborator
Cardiovascular Academy Society, Turkey

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary ischemia ischemic events of patients on dual antiplatelet therapy 3 months
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