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Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes (TIMACS)

Primary Purpose

Unstable Angina, Myocardial Infarction

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Early Coronary Intervention

Delayed Coronary Intervention

About this trial

This is an interventional treatment trial for Unstable Angina focused on measuring timing, intervention, early, delayed, acute coronary syndromes, PCI, angiography, Non ST-segment elevation myocardial infarction, unstable angina

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hamilton Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Early Coronary Intervention

Delayed Coronary Intervention

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Stroke at 30 Days and 180 Days

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

In-hospital Major Bleeding

Full Information

NCT ID

NCT00552513

First Posted

October 30, 2007

Last Updated

April 19, 2022

Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT00552513

Brief Title

Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes

Acronym

TIMACS

Official Title

An International Randomised Trial of Early Versus Delayed Invasive Strategies in Patients With Non-ST Segment Elevation Acute Coronary Syndromes

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

May 2005 (undefined)

Primary Completion Date

July 2008 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Population Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR), Hamilton Health Sciences Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Unstable Angina, Myocardial Infarction

Keywords

timing, intervention, early, delayed, acute coronary syndromes, PCI, angiography, Non ST-segment elevation myocardial infarction, unstable angina

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

3031 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Early Coronary Intervention

Arm Type

Other

Arm Description

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).

Arm Title

Delayed Coronary Intervention

Arm Type

Other

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Early Coronary Intervention

Intervention Description

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).

Intervention Type

Procedure

Intervention Name(s)

Delayed Coronary Intervention

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

180 days

Secondary Outcome Measure Information:

Title

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

Time Frame

180 days

Title

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

Time Frame

180 days

Title

Stroke at 30 Days and 180 Days

Time Frame

180 days

Title

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

Time Frame

180 days

Title

In-hospital Major Bleeding

Time Frame

Hospital discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shamir Mehta, MD, MSc

Organizational Affiliation

Population Health Research Institute, Hamilton Health Sciences, McMaster University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hamilton Health Sciences

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8L 2X2

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

16338245

Citation

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.

Results Reference

background

PubMed Identifier

19458363

Citation

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.

Results Reference

result

Links:

URL

http://www.phri.ca

Description

Population Health Research Institute

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Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes

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