Clinical trial NCT00552513: Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes
Official title: An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unstable Angina
Myocardial Infarction
Keywords: timing
intervention
early
delayed
acute coronary syndromes
PCI
angiography
Non ST-segment elevation myocardial infarction
unstable angina
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Hamilton Health Sciences Corporation
First posted: 2007-11-02
Enrollment: 3031
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

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

Primary outcomes:
measure: Composite of Death, Myocardial (re-) Infarction, or Stroke
timeFrame: 180 days
Secondary outcomes:
measure: First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia
timeFrame: 180 days
measure: Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days
timeFrame: 180 days
measure: Stroke at 30 Days and 180 Days
timeFrame: 180 days
measure: Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180
timeFrame: 180 days
measure: In-hospital Major Bleeding
timeFrame: Hospital discharge
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Hamilton Health Sciences
state: Ontario
Study officials:
affiliation: Population Health Research Institute, Hamilton Health Sciences, McMaster University
name: Shamir Mehta, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: MICHELANGELO OASIS 5 Steering Committee; Mehta SR, Yusuf S, Granger CB, Wallentin L, Peters RJ, Bassand JP, Budaj A, Joyner C, Chrolavicius S, Fox KA. Design and rationale of the MICHELANGELO Organization to Assess Strategies in Acute Ischemic Syndromes (OASIS)-5 trial program evaluating fondaparinux, a synthetic factor Xa inhibitor, in patients with non-ST-segment elevation acute coronary syndromes. Am Heart J. 2005 Dec;150(6):1107. doi: 10.1016/j.ahj.2005.09.025.
citation: Mehta SR, Granger CB, Boden WE, Steg PG, Bassand JP, Faxon DP, Afzal R, Chrolavicius S, Jolly SS, Widimsky P, Avezum A, Rupprecht HJ, Zhu J, Col J, Natarajan MK, Horsman C, Fox KA, Yusuf S; TIMACS Investigators. Early versus delayed invasive intervention in acute coronary syndromes. N Engl J Med. 2009 May 21;360(21):2165-75. doi: 10.1056/NEJMoa0807986.