NCT00552513

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,031

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2005

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 2, 2007

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
5.4 years until next milestone

Results Posted

Study results publicly available

June 27, 2014

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

3.2 years

First QC Date

October 30, 2007

Results QC Date

May 27, 2014

Last Update Submit

April 19, 2022

Conditions

Unstable AnginaMyocardial Infarction

Keywords

timinginterventionearlydelayedacute coronary syndromesPCIangiographyNon ST-segment elevation myocardial infarctionunstable angina

Outcome Measures

Primary Outcomes (1)

  • Composite of Death, Myocardial (re-) Infarction, or Stroke

    180 days

Secondary Outcomes (5)

  • First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia

    180 days

  • Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days

    180 days

  • Stroke at 30 Days and 180 Days

    180 days

  • Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180

    180 days

  • In-hospital Major Bleeding

    Hospital discharge

Study Arms (2)

Early Coronary Intervention

OTHER

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 Coronary Intervention

Delayed Coronary Intervention

OTHER

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 Coronary Intervention

Interventions

Early Coronary InterventionPROCEDURE

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).

Early Coronary Intervention
Delayed Coronary InterventionPROCEDURE

Perform coronary angiography and intervention (either percutaneous coronary intervention \[PCI\] or coronary artery bypass graft \[CABG\] surgery) any time after 36 hours after randomisation.

Delayed Coronary Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Age less than 21 years
  • Not a suitable candidate for revascularisation
  • Co-morbid condition with life expectancy less than six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8L 2X2, Canada

Location

Related Publications (2)

  • 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. doi: 10.1016/j.ahj.2005.09.025.

    PMID: 16338245BACKGROUND

  • 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. doi: 10.1056/NEJMoa0807986.

    PMID: 19458363RESULT

Related Links

MeSH Terms

Conditions

Angina, UnstableMyocardial InfarctionAcute Coronary Syndrome

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsInfarctionIschemiaPathologic ProcessesNecrosis

Results Point of Contact

Title
TIMACS Project Office
Organization
Population Health Research Institute
timacs@phri.ca
19055244322

Study Officials

  • Shamir Mehta, MD, MSc

    Population Health Research Institute, Hamilton Health Sciences, McMaster University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2007

First Posted

November 2, 2007

Study Start

May 1, 2005

Primary Completion

July 1, 2008

Study Completion

February 1, 2009

Last Updated

April 21, 2022

Results First Posted

June 27, 2014

Record last verified: 2022-04

Locations

CA(1)