N/A
N=3,031
Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes
Unstable Angina · Myocardial Infarction
Bottom Line
View on ClinicalTrials.gov: NCT00552513 ↗Enrolled (actual)
3,031
Serious AEs
—
Results posted
Jun 2014
Primary outcome: Primary: Composite of Death, Myocardial (re-) Infarction, or Stroke — 153; 163 participants — p=0.15
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Early Coronary Intervention (Procedure); Delayed Coronary Intervention (Procedure)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Population Health Research Institute
- Primary completion
- Jul 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite of Death, Myocardial (re-) Infarction, or Stroke |
153; 163 | 0.15 |
| SECONDARY First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia |
151; 186 | 0.003 sig |
| SECONDARY Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days |
264; 280 | 0.04 sig |
| SECONDARY Stroke at 30 Days and 180 Days |
— | — |
| SECONDARY Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180 |
— | — |
| SECONDARY In-hospital Major Bleeding |
— | — |
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).
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00552513). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.