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Completed

NCT Number: NCT00552513

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

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).

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Key information

Conditions

Unstable Angina Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Early Coronary Intervention

Procedure

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).

Delayed Coronary Intervention

Procedure

Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.

Primary outcomes

  1. Composite of Death, Myocardial (re-) Infarction, or Stroke

    Time frame: 180 days

Secondary outcomes

  1. First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia

    Time frame: 180 days

  2. Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days

    Time frame: 180 days

  3. Stroke at 30 Days and 180 Days

    Time frame: 180 days

  4. Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180

    Time frame: 180 days

  5. In-hospital Major Bleeding

    Time frame: Hospital discharge

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Hamilton Health Sciences Corporation

Registry information

Official study title

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

Acronym: TIMACS

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Nov 2, 2007
Registry last updated
Apr 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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