An observational study in Major Bleeding and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE), sponsored by Jordan Collaborating Cardiology Group. Recruiting at 2 sites in Jordan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-28.
Sponsored by Jordan Collaborating Cardiology Group · Observational
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?
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.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's planned enrollment of 200 is below the median of 500 across 590 observational studies indexed under Acute Coronary Syndrome.
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The study will enroll adult patients, men and women, who present to the emergency department (ED) with acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, and unstable angina) and who are prescribed aspirin in the ED and a second oral antiplatelet medication either in the ED (not according to recent guidelines) or upon identification of the coronary anatomy in the cath lab (based on recent guidelines). Incidence of bleeding and other cardiovascular events in these patients based in timing of administering the antiplatelet therapy.
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Exclusion Criteria:
Patients with ACS presenting to the ED with a planned coronary angiography for possible coronary revascularization who get aspirin in the ED will be evaluated for bleeding and major cardiovascular events when they receive a second antiplatelet agent in the ED compared with in the cath lab.
Major bleeding event
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 the end of the study at 1 year.
Major adverse cardiovascular and cerebral events
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.
Time frame: from enrollment to 1 year
Plan to share: Undecided
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Jordan Collaborating Cardiology Group