Pretreatment of Acute Coronary Syndrome With Dual Antiplatelet Agents (DATES)

Dual Antiplatelet Agents Therapy in the Emergency Department for Acute Coronary Syndrome (The DATES Study).

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?

Study Overview

• Status: Recruiting
• Conditions: Major Bleeding; Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ayman Hammoudeh, MD, FACC; Phone Number: +96265001000; Email: hammoudeh_ayman@yahoo.com
• Study Contact Backup: Name: Laith Habahbeh, MD; Phone Number: 065001000; Email: researchcultire2020@gmail.com

Study Locations

• Jordan
  • Amman, Jordan, 11184
    • Not yet recruiting
    • Istishari Hospital
    • Contact: Ayman Hammoudeh, MD, FACC; Phone Number: 065001000; Email: hammoudeh_ayman@yahoo.com
    • Contact: Laith Habahbeh, MD; Phone Number: 065001000; Email: researchculture2020@gmail.com
    • Sub-Investigator: Rashid Hnaiti, MD
  • Amman, Jordan, 11180
    • Recruiting
    • Jordan University Hospital
    • Contact: Ayman Hammoudeh, MD, FACC; Phone Number: 065001000; Email: hammoudeh_ayman@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Non cardiac chest pain.
• No administration of antiplatelet agents during hospitalization.
• Refusal of contact for follow up.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Adult patients admitted for acute coronary syndrome via the ED; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From enrollment to the end of the study at 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	from enrollment to 1 year

Collaborators and Investigators

• Sponsor: Jordan Collaborating Cardiology Group

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 18, 2025
• First Submitted That Met QC Criteria: June 18, 2025
• First Posted (Actual): June 26, 2025

Study Record Updates

• Last Update Posted (Actual): November 28, 2025
• Last Update Submitted That Met QC Criteria: November 26, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: Acute coronary syndrome; Dual antiplatelet therapy; Pretreatment with DAPT
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: DATES.2.25/irbIH1725

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No