Trial Outcomes & Findings for Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes (NCT NCT00552513)
NCT ID: NCT00552513
Last Updated: 2022-04-21
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3031 participants
Primary outcome timeframe
180 days
Results posted on
2022-04-21
Participant Flow
Participant milestones
| Measure |
Early
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
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.
|
|---|---|---|
|
Overall Study
STARTED
|
1593
|
1438
|
|
Overall Study
COMPLETED
|
1588
|
1437
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
Reasons for withdrawal
| Measure |
Early
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
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
Baseline Characteristics
Early Versus Delayed Timing of Intervention in Patients With Acute Coronary Syndromes
Baseline characteristics by cohort
| Measure |
Early
n=1593 Participants
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
n=1438 Participants
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
n=3031 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age
|
65.1 years
STANDARD_DEVIATION 0 • n=5 Participants
|
65.8 years
STANDARD_DEVIATION 0 • n=7 Participants
|
65.5 years
STANDARD_DEVIATION 0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
554 Participants
n=5 Participants
|
498 Participants
n=7 Participants
|
1052 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1039 Participants
n=5 Participants
|
940 Participants
n=7 Participants
|
1979 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 daysPopulation: 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.
Outcome measures
| Measure |
Early Intervention
n=1593 Participants
Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
|
Delayed Intervention
n=1438 Participants
Coronary angiography to be performed after a minimum delay of 36 hours after randomization
|
|---|---|---|
|
Composite of Death, Myocardial (re-) Infarction, or Stroke
|
153 participants
Interval 0.68 to 1.06
|
163 participants
Interval 0.68 to 1.06
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Early Intervention
n=1593 Participants
Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
|
Delayed Intervention
n=1438 Participants
Coronary angiography to be performed after a minimum delay of 36 hours after randomization
|
|---|---|---|
|
First Occurrence of Any Component of the Composite of Death, MI, or Refractory Ischemia
|
151 participants
|
186 participants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
| Measure |
Early Intervention
n=1593 Participants
Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
|
Delayed Intervention
n=1438 Participants
Coronary angiography to be performed after a minimum delay of 36 hours after randomization
|
|---|---|---|
|
Composite of Death, MI, Stroke, Refractory Ischemia or Repeat Revascularization at 180 Days
|
264 Eparticipants
|
280 Eparticipants
|
SECONDARY outcome
Timeframe: 180 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 daysOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Hospital dischargeOutcome measures
Outcome data not reported
Adverse Events
Early
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
TIMACS Project Office
Population Health Research Institute
Phone: 19055244322
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER