TiMing of Intervention in patients with Acute Coronary Syndromes

ISRCTN ISRCTN20993046
DOI https://doi.org/10.1186/ISRCTN20993046
ClinicalTrials.gov number NCT00552513
Secondary identifying numbers MCT-79654
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

Study designTherapeutic management strategy and procedures intervention type randomised parallel two-armed multicentre multi-national trial with accessor blinding
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleAn International randomised trial of early versus delayed invasive strategies in patients with non-ST segment elevation acute coronary syndromes
Study acronymTIMACS
Study objectives1. 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) studiedAcute coronary syndromes (unstable angina and non-ST segment elevation myocardial infarction)
InterventionEarly 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 typeProcedure/Surgery
Primary outcome measureThe first occurrence of the composite death/myocardial (re-)infarction/stroke up to day 180.
Secondary outcome measures1. 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 study start date15/06/2005
Completion date01/05/2008

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants4000
Key inclusion criteria1. 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 criteria1. 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 enrolment15/06/2005
Date of final enrolment01/05/2008

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

Sponsor information

Population Health Research Institute (PHRI) (Canada)
Research organisation

McMaster University/Hamilton Health Sciences
237 Barton St East
Hamilton, Ontario
L8L 2X2
Canada

Phone +1 (0)905 527 4322 ext. 44555
Email crackbe@phri.ca
Website http://www.phri.ca
ROR logo "ROR" https://ror.org/03kwaeq96

Funders

Funder type

Research organisation

Canadian Institutes of Health Research
Government organisation / National government
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location
Canada

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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

Editorial Notes

10/04/2019: Publication reference added.