Pretreatment of Acute Coronary Syndrome With Dual Antiplatelet Agents
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorJordan Collaborating Cardiology Group
About this trial
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?
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult patients
Presenting with acute coronary syndrome (ST segment elevation myocardial infarction, non ST segment elevation myocardial infarction, and unstable angina).
Antiplatelet medication (s) prescribed during index admission to hospital.
Willingness of the patient to be called for follow up up to 1 year after index hospitalization.
Disqualifiers
Non cardiac chest pain.
No administration of antiplatelet agents during hospitalization.
Refusal of contact for follow up.
Trial population
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.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
200 Participants
are grouped into 1 trial groupGroup A: Adult patients admitted for acute coronary syndrome via the ED
Trial outcomes
Primary outcomes
1
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.Secondary outcomes
1
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 yearSponsors and contacts
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Source ClinicalTrials.gov