Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes - Full Text View

Sponsor:	Population Health Research Institute
Collaborators:	Canadian Institutes of Health Research (CIHR) Hamilton Health Sciences Corporation
Information provided by:	Population Health Research Institute
ClinicalTrials.gov Identifier:	NCT00552513

Purpose

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).

Condition	Intervention
Unstable Angina Myocardial Infarction	Procedure: Early Intervention (coronary angiography and intervention - either PCI or CABG) Procedure: Delayed Intervention (coronary angiography and intervention - either PCI or CABG)

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes

Resource links provided by NLM:

MedlinePlus related topics: Angina Coronary Artery Bypass Surgery Heart Attack

U.S. FDA Resources

Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:

Composite of death, myocardial (re-) infarction, or stroke [ Time Frame: 180 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Composite of Death, MI, Stroke, Refractory Ischemia or repeat revascularization at 180 days [ Time Frame: 180 days ] [ Designated as safety issue: No ]
First occurrence of any component of the composite of death, MI, and refractory ischemia until day 14, 30, 90 and 180 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Stroke at 30 days and 180 days [ Time Frame: 180 days ] [ Designated as safety issue: No ]
Need for mechanical or pharmacological coronary revascularization (i.e. thrombolysis, PCI, CABG) at days 30, 90, and 180 [ Time Frame: 180 days ] [ Designated as safety issue: No ]
In-hospital major bleeding [ Time Frame: Hospital discharge ] [ Designated as safety issue: Yes ]

Enrollment:	3031
Study Start Date:	May 2005
Study Completion Date:	February 2009
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

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

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00552513

Locations

Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8L 2X2

Sponsors and Collaborators

Population Health Research Institute

Canadian Institutes of Health Research (CIHR)

Hamilton Health Sciences Corporation

Investigators

Principal Investigator:

Shamir Mehta, MD, MSc

Population Health Research Institute, Hamilton Health Sciences, McMaster University

More Information

Additional Information:

Population Health Research Institute This link exits the ClinicalTrials.gov site

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Craig Horsman - Research Coordinator, Population Health Research Institute
ClinicalTrials.gov Identifier:	NCT00552513 History of Changes
Other Study ID Numbers:	FRN: MCT-79654, ISRCTN20993046
Study First Received:	October 30, 2007
Last Updated:	April 27, 2009
Health Authority:	Canada: Canadian Institutes of Health Research; Canada: Ethics Review Committee; Australia: Human Research Ethics Committee; Brazil: National Committee of Ethics in Research; Belgium: Institutional Review Board; Colombia: Institutional Review Board; Czech Republic: Ethics Committee; India: Institutional Review Board; Romania: National Medicines Agency; Thailand: Ethical Committee; United States: Institutional Review Board

Keywords provided by Population Health Research Institute:

timing
intervention
early
delayed
acute coronary syndromes

PCI
angiography
Non ST-segment elevation myocardial infarction
unstable angina
Acute Coronary Syndromes

Additional relevant MeSH terms:

Angina, Unstable
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Angina Pectoris
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases

Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on February 09, 2012