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

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ClinicalTrials.gov Identifier: NCT00552513
Recruitment Status : Completed
First Posted : November 2, 2007
Results First Posted : June 27, 2014
Last Update Posted : June 27, 2014
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Hamilton Health Sciences Corporation
Information provided by (Responsible Party):
Population Health Research Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Unstable Angina
Myocardial Infarction
Interventions Procedure: Early Coronary Intervention
Procedure: Delayed Coronary Intervention
Enrollment 3031
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Early Delayed
Hide Arm/Group 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.
Period Title: Overall Study
Started 1593 1438
Completed 1588 1437
Not Completed 5 1
Reason Not Completed
Lost to Follow-up             5             1
Arm/Group Title Early Delayed Total
Hide Arm/Group 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. Total of all reporting groups
Overall Number of Baseline Participants 1593 1438 3031
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Standard Deviation)
Unit of measure:  Years
Age Number Analyzed 1593 participants 1438 participants 3031 participants
65.1  (0) 65.8  (0) 65.5  (0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1593 participants 1438 participants 3031 participants
Female
554
  34.8%
498
  34.6%
1052
  34.7%
Male
1039
  65.2%
940
  65.4%
1979
  65.3%
1.Primary Outcome
Title Composite of Death, Myocardial (re-) Infarction, or Stroke
Hide Description [Not Specified]
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
All patients were included in the final intention-to-treat analysis. Event rates in the two groups were estimated with the use of the Kaplan-Meier method. The hazard ratio and two-sided 95% confidence intervals were calculated with the use of a Cox proportional-hazards model.
Arm/Group Title Early Intervention Delayed Intervention
Hide Arm/Group Description:
Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
Coronary angiography to be performed after a minimum delay of 36 hours after randomization
Overall Number of Participants Analyzed 1593 1438
Measure Type: Number
Unit of Measure: participants
153 163
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Intervention, Delayed Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.15
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.68 to 1.06
Estimation Comments [Not Specified]
2.Secondary Outcome
Title First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia
Hide Description [Not Specified]
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Intervention Delayed Intervention
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1593 1438
Measure Type: Number
Unit of Measure: participants
151 186
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Intervention, Delayed Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.72
Confidence Interval (2-Sided) 95%
0.58 to 0.89
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days
Hide Description [Not Specified]
Time Frame 180 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Early Intervention Delayed Intervention
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 1593 1438
Measure Type: Number
Unit of Measure: Eparticipants
264 280
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Early Intervention, Delayed Intervention
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.71 to 0.99
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Stroke at 30 Days and 180 Days
Hide Description [Not Specified]
Time Frame 180 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Need for Mechanical or Pharmacological Coronary Revascularization (i.e. Thrombolysis, PCI, CABG) at Days 30, 90, and 180
Hide Description [Not Specified]
Time Frame 180 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title In-hospital Major Bleeding
Hide Description [Not Specified]
Time Frame Hospital discharge
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Early Delayed
Hide Arm/Group 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.
All-Cause Mortality
Early Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Early Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Early Delayed
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PHRI agreements may vary with individual investigators, but will not prohibit any investigator from publishing. PHRI supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: TIMACS Project Office
Organization: Population Health Research Institute
Phone: 19055244322
EMail: timacs@phri.ca
Layout table for additonal information
Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT00552513    
Other Study ID Numbers: FRN: MCT-79654
ISRCTN20993046 ( Registry Identifier: International Standard Randomised Controlled Trial Number )
First Submitted: October 30, 2007
First Posted: November 2, 2007
Results First Submitted: May 27, 2014
Results First Posted: June 27, 2014
Last Update Posted: June 27, 2014