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Recruiting NCT07039149

Pretreatment of Acute Coronary Syndrome With Dual Antiplatelet Agents

Observational Major Bleeding Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Major Bleeding, Major Adverse Cardiovascular and Cerebrovascular Events (MACCE). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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?

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.

Primary outcome measures

  • Major bleeding event [Time frame: From enrollment to the end of the study at 1 year.]
Secondary outcome measures (1)
  • Major adverse cardiovascular and cerebral events [Time frame: from enrollment to 1 year]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Jordan · 2 centers
  • Jordan University Hospital — Amman
  • Istishari Hospital — Amman

Identifiers

NCT: NCT07039149 · DATES.2.25/irbIH1725

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗