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

Myocardial Infarction Clinical Trial

— TIMACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00552513
• Other study ID #: FRN: MCT-79654
• Secondary ID: ISRCTN20993046
• Status: Completed
• Phase: N/A
• Start date: May 2005
• Est. completion date: February 2009

Study information

• Verified date: April 2022
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3031
• Est. completion date: February 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina, Unstable
• Infarction
• Myocardial Infarction
• Unstable Angina

Intervention

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

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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 — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of Death, Myocardial (re-) Infarction, or Stroke		180 days
Secondary	First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia		180 days
Secondary	Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days		180 days
Secondary	Stroke at 30 Days and 180 Days		180 days
Secondary	Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180		180 days
Secondary	In-hospital Major Bleeding		Hospital discharge

External Links

•   Population Health Research Institute