- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00552513
Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes (TIMACS)
April 19, 2022 updated by: Population Health Research Institute
An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation 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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
3031
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Ontario
-
Hamilton, Ontario, Canada, L8L 2X2
- Hamilton Health Sciences
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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).
|
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).
|
Other: 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.
|
Perform coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Composite of Death, Myocardial (re-) Infarction, or Stroke
Time Frame: 180 days
|
180 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia
Time Frame: 180 days
|
180 days
|
Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days
Time Frame: 180 days
|
180 days
|
Stroke at 30 Days and 180 Days
Time Frame: 180 days
|
180 days
|
Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180
Time Frame: 180 days
|
180 days
|
In-hospital Major Bleeding
Time Frame: Hospital discharge
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Hospital discharge
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Shamir Mehta, MD, MSc, Population Health Research Institute, Hamilton Health Sciences, McMaster University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2005
Primary Completion (Actual)
July 1, 2008
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
October 30, 2007
First Submitted That Met QC Criteria
November 1, 2007
First Posted (Estimate)
November 2, 2007
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FRN: MCT-79654
- ISRCTN20993046 (Registry Identifier: International Standard Randomised Controlled Trial Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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