TiMing of Intervention in patients with Acute Coronary Syndromes

ISRCTN	ISRCTN20993046
DOI	https://doi.org/10.1186/ISRCTN20993046
ClinicalTrials.gov (NCT)	NCT00552513
Protocol serial number	MCT-79654
Sponsor	Population Health Research Institute (PHRI) (Canada)
Funder	Canadian Institutes of Health Research

Submission date: 27/11/2006
Registration date: 27/11/2006
Last edited: 10/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Shamir Mehta
Scientific

Hamilton Health Sciences
General Division
237 Barton Street
McMaster Clinic
Room 508
Hamilton, Ontario
L8L 2X2
Canada

Ms Brandi Meeks
Public

Population Health Research Institute (PHRI)
McMaster University/Hamilton Health Sciences
237 Barton St E
Hamilton
ON L8L 2X2
Canada

Phone	+1 (0)905 527 4322 ext. 44818
Email	brandi@cardio.on.ca

Study information

Primary study design	Interventional
Study design	Therapeutic management strategy and procedures intervention type randomised parallel two-armed multicentre multi-national trial with accessor blinding
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	An International randomised trial of early versus delayed invasive strategies in patients with non-ST segment elevation acute coronary syndromes
Study acronym	TIMACS
Study objectives	1. In patients with acute coronary syndromes (ACS), a strategy of routine early coronary angiography (less than 24 hours after randomisation) and intervention is superior to a strategy of delayed coronary angiography (more than 36 hours after randomisation) and intervention in preventing major cardiovascular events 2. In patients with ACS, a delayed invasive strategy will result in lower rates of major bleeding versus a strategy of early angiography and revascularisation 3. A strategy of early coronary angiography and revascularisation will be more cost effective than a strategy of delayed coronary angiography and revascularisation
Ethics approval(s)	1. Research Ethics Board of the Hamilton Health Sciences/McMaster Health Sciences, Hamilton, Ontario, Canada, 26/05/2005 2. Comité de Ética em Pesquisa, Santa Casa de Belo Horizonte, Belo Horizonte, Brazil, 29/05/2006 3. Comité d'Ethique Médicale, Centre Hospitauer Regional De Huy, De Huy, Belgium, 12/10/2005 4. Ethics Committee of the Middle Slovak Institute of Cardiovascular Diseases, Banska Bistrica, Slovakia, 26/10/2006 5. University Clinical Emergency Hospital Mures Clinic of Cardiology, Targu Mures, Romania, 01/11/2006
Health condition(s) or problem(s) studied	Acute coronary syndromes (unstable angina and non-ST segment elevation myocardial infarction)
Intervention	Early intervention: Coronary angiography and intervention as soon as possible (within 24 hours of randomisation). Delayed intervention: Coronary angiography and intervention any time after 36 hours after randomisation.
Intervention type	Procedure/Surgery
Primary outcome measure(s)	The first occurrence of the composite death/myocardial (re-)infarction/stroke up to day 180.
Key secondary outcome measure(s)	1. The composite of death, myocardial (re-)infarction, stroke, refractory ischaemia or repeat revascularisation at 180 days 2. The first occurrence of any component of the composite of death myocardial infarction and refractory ischaemia until day 14, 30, 90 and at six months (day 180) 3. Stroke at 30 days and 180 days 4. Need for mechanical or pharmacological coronary revascularisation (i.e., percutaneous coronary intervention [PCI], coronary artery bypass graft [CABG], thrombolysis) at days 30, 90 and 180 days
Completion date	01/05/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	4000
Key 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 ischaemic chest pain or ischaemic 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: 3.1. Age more than or equal to 60 years, either sex 3.2. Troponin T or I or creatine kinase - myocardial bands (CK-MB) above the upper limit of normal for the local institution 3.3. Electrocardiogram (ECG) changes compatible with ischaemia (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
Key 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
Date of first enrolment	15/06/2005
Date of final enrolment	01/05/2008

Locations

Countries of recruitment

Argentina
Belgium
Brazil
Bulgaria
Canada
Chile
China
Czech Republic
France
Germany
Greece
India
Poland
Romania
Slovakia
Slovenia
Switzerland
United States of America

Study participating centre

Hamilton Health Sciences

Hamilton, Ontario
L8L 2X2
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	21/05/2009	10/04/2019	Yes	No
Basic results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

10/04/2019: Publication reference added.