Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes

Study Overview
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Brief Summary
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The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS).

Official Title
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An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes

Conditions
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Unstable Angina, Myocardial Infarction

Intervention / Treatment
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* Procedure: Early Coronary Intervention
* Procedure: Delayed Coronary Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients presenting or admitted to hospital with symptoms suspected to represent an acute coronary syndrome (unstable angina or MI without persistent ST elevation) i.e., clinical history consistent with new onset, or a worsening pattern, of characteristic ischemic chest pain or ischemic symptoms occurring at rest or with minimal activity (lasting longer than five minutes or requiring sublingual nitroglycerin for relief of the pain) Able to randomise within 24 hours of the onset of the most recent episode of symptoms At least two of the three following additional criteria: Age more than or equal to 60 years Troponin T or I or Creatine Kinase - Myocardial Bands (CK-MB) above the upper limit of normal for the local institution ElectroCardioGram (ECG) changes compatible with ischemia (i.e., ST depression at least 1 mm in two contiguous leads or T wave inversion mroe than 3 mm or any dynamic ST shift or transient ST elevation) Written informed consent dated and signed Exclusion Criteria: Age less than 21 years Not a suitable candidate for revascularisation Co-morbid condition with life expectancy less than six months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Early Coronary Intervention<br>Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation). | Procedure: Early Coronary Intervention<br>* Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (and within 24 hours of randomisation).<br>|
| Other: Delayed Coronary Intervention<br>Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation. | Procedure: Delayed Coronary Intervention<br>* Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite of Death, Myocardial (re-) Infarction, or Stroke |  | 180 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia |  | 180 days | 
| Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days |  | 180 days | 
| Stroke at 30 Days and 180 Days |  | 180 days | 
| Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180 |  | 180 days | 
| In-hospital Major Bleeding |  | Hospital discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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timing, intervention, early, delayed, acute coronary syndromes, PCI, angiography, Non ST-segment elevation myocardial infarction, unstable angina