A Study to Describe the Characteristics, Health Care Interventions and Outcomes of Patients With Major Bleedings in the Presence of Factor Xa Inhibitor Treatment
NCT06147830
Major Bleeding
Chandler, Arizona, United States
View Trial DetailsNCT Number: NCT07039149
This is a chart review of data on use of antiplatelet (AP) medications for acute coronary syndrome in the ER. Guidelines recommend giving aspirin in the ER and a second AP agent in the cath lab. What is the outcome when the 2 agents are given n the ER?
Interested in participating?
Request Info18 year and older
All sexes
Observational
Istishari Hospital, Amman, Jordan
Dual antiplatelet therapy (DAPT) is a standard treatment in ST-elevation myocardial infarction (STEMI) and non-ST-segment-elevation acute coronary syndrome (NSTEACS) . However, the timing of initiation of DAPT in the Emergency Department (ED) has been defined by recent western guidelines (i.e., aspirin in the ER and and a second AP agent when the coronary anatomy has been denied in the cath lab. This strategy aims at decreasing the incidence of bleeding events. However, patients with ACS in the Middle East are younger than those in the West and have lower bleeding risk. The purpose of this study is to evaluate the incidence of major bleeding in patients who received DAPT in the ED according to the discretion of the treating physician.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: From enrollment to the end of the study at 1 year.
Major bleeding event is defined as any of the following: 1. bleeding causing hemodynamic compromise, 2. bleeding necessitating blood transfusion, or 3. bleeding in a closed space (intracerebral intraspinal and intraocular).
Time frame: from enrollment to 1 year
Occurrence of any of the followings: 1. Cardiovascular death (death due to documented cardiovascular event: fatal myocardial infarction, or fatal stroke), 2. Non fatal myocardial infarction (two of three criteria: ischemic chest pain, electrocardiographic changes [ST segment deviation and T wave inversion] and elevated cardiac enzymes), 2. Definite stent thrombosis (demonstrating a thrombus in the stent on coronary angiography), 3. Non fatal stroke (new neurological deficit compatible with cerebral ischemia, brain imaging by computed tomography or magnetic resonance showing typical stroke, ischemic or hemorrhagic), 4. Coronary revascularization by percutaneous intervention or coronary bypass surgery.
Contact information is provided by the study sponsor or research team.
Ayman Hammoudeh, MD, FACC
CONTACT
Laith Habahbeh, MD
CONTACT
Jordan Collaborating Cardiology Group
Other
Dual Antiplatelet Agents Therapy in the Emergency Department for Acute Coronary Syndrome (The DATES Study).
Acronym: DATES
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