Condition category
Circulatory System
Date applied
27/11/2006
Date assigned
27/11/2006
Last edited
23/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shamir Mehta

ORCID ID

Contact details

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

Type

Public

Additional contact

Ms Brandi Meeks

ORCID ID

Contact details

Population Health Research Institute (PHRI)
McMaster University/Hamilton Health Sciences
237 Barton St E
Hamilton
ON L8L 2X2
Canada
+1 (0)905 527 4322 ext. 44818
brandi@cardio.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00552513

Protocol/serial number

MCT-79654

Study information

Scientific title

An International randomised trial of early versus delayed invasive strategies in patients with non-ST segment elevation acute coronary syndromes

Acronym

TIMACS

Study hypothesis

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

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

Study design

Therapeutic management strategy and procedures intervention type randomised parallel two-armed multicentre multi-national trial with accessor blinding

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

The first occurrence of the composite death/myocardial (re-)infarction/stroke up to day 180.

Secondary outcome measures

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

Overall trial start date

15/06/2005

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

4000

Participant 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

Recruitment start date

15/06/2005

Recruitment end date

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

Trial participating centre

Hamilton Health Sciences
Hamilton, Ontario
L8L 2X2
Canada

Sponsor information

Organisation

Population Health Research Institute (PHRI) (Canada)

Sponsor details

McMaster University/Hamilton Health Sciences
237 Barton St East
Hamilton
Ontario
L8L 2X2
Canada
+1 (0)905 527 4322 ext. 44555
crackbe@phri.ca

Sponsor type

Research organisation

Website

http://www.phri.ca

Funders

Funder type

Research organisation

Funder name

Canadian Institutes of Health Research

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

See https://clinicaltrials.gov/ct2/show/results/NCT00552513

Publication summary

Publication citations

Additional files

Editorial Notes