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

Not Applicable

Completed

• Conditions: Myocardial Infarction; Unstable Angina
• Interventions: Procedure: Delayed Coronary Intervention; Procedure: Early Coronary Intervention

• Registration Number: NCT00552513
• Lead Sponsor: Population Health Research Institute

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2007-10-30
• Study First Submitted QC: 2007-11-01
• Study First Posted: 2007-11-02
• Primary Completion: 2008-07
• Study Completion: 2009-02
• Results First Submitted: 2014-05-27
• Results First Submitted QC: 2014-05-27
• Results First Posted: 2014-06-27
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3031

Inclusion Criteria

1. 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)

2. Able to randomise within 24 hours of the onset of the most recent episode of symptoms

3. 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)

4. Written informed consent dated and signed

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Exclusion Criteria

1. Age less than 21 years
2. Not a suitable candidate for revascularisation
3. Co-morbid condition with life expectancy less than six months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Delayed Coronary Intervention	Delayed Coronary Intervention	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.
Early Coronary Intervention	Early Coronary Intervention	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).

Primary Outcome Measures

Name	Time	Method
Composite of Death, Myocardial (re-) Infarction, or Stroke	180 days

Secondary Outcome Measures

Name	Time	Method
First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia	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
Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days	180 days

Trial Locations

Locations (1)

Hamilton Health Sciences; 🇨🇦 Hamilton, Ontario, Canada