Trial Outcomes & Findings for Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation (NCT NCT00445263)
NCT ID: NCT00445263
Last Updated: 2015-02-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
170 participants
Primary outcome timeframe
d30
Results posted on
2015-02-27
Participant Flow
Participant milestones
| Measure |
Early Invasive Strategy
Tirofiban and coronarography within six hours
|
Delayed Invasive Strategy
Coronarography after six hours
|
|---|---|---|
|
Overall Study
STARTED
|
83
|
87
|
|
Overall Study
COMPLETED
|
83
|
86
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Two Treatment Strategies in Patients With an Acute Coronary Syndrome Without ST Elevation
Baseline characteristics by cohort
| Measure |
Early Invasive Strategy
n=83 Participants
Tirofiban and coronarography within six hours
|
Delayed Invasive Strategy
n=86 Participants
Coronarography after six hours
|
Total
n=169 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.9 years
n=99 Participants
|
66.5 years
n=107 Participants
|
65.3 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
58 Participants
n=99 Participants
|
63 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
BMI
|
27.0 kg/m2
n=99 Participants
|
26.6 kg/m2
n=107 Participants
|
26.6 kg/m2
n=206 Participants
|
|
Family history of CVS disease
Yes
|
20 participants
n=99 Participants
|
22 participants
n=107 Participants
|
42 participants
n=206 Participants
|
|
Family history of CVS disease
No
|
63 participants
n=99 Participants
|
64 participants
n=107 Participants
|
127 participants
n=206 Participants
|
|
Current smoker
Yes
|
44 participants
n=99 Participants
|
41 participants
n=107 Participants
|
85 participants
n=206 Participants
|
|
Current smoker
No
|
39 participants
n=99 Participants
|
45 participants
n=107 Participants
|
84 participants
n=206 Participants
|
|
Diabetes mellitus
Yes
|
35 participants
n=99 Participants
|
28 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
Diabetes mellitus
No
|
48 participants
n=99 Participants
|
58 participants
n=107 Participants
|
106 participants
n=206 Participants
|
|
Hypertension
Yes
|
50 participants
n=99 Participants
|
51 participants
n=107 Participants
|
101 participants
n=206 Participants
|
|
Hypertension
No
|
33 participants
n=99 Participants
|
35 participants
n=107 Participants
|
68 participants
n=206 Participants
|
|
Dyslipidemia
Yes
|
45 participants
n=99 Participants
|
45 participants
n=107 Participants
|
90 participants
n=206 Participants
|
|
Dyslipidemia
No
|
38 participants
n=99 Participants
|
41 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Previous MI
Yes
|
19 participants
n=99 Participants
|
20 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
Previous MI
No
|
64 participants
n=99 Participants
|
66 participants
n=107 Participants
|
130 participants
n=206 Participants
|
|
Previous PCI
Yes
|
20 participants
n=99 Participants
|
18 participants
n=107 Participants
|
38 participants
n=206 Participants
|
|
Previous PCI
No
|
63 participants
n=99 Participants
|
68 participants
n=107 Participants
|
131 participants
n=206 Participants
|
|
Previous CABG
Yes
|
8 participants
n=99 Participants
|
4 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Previous CABG
No
|
75 participants
n=99 Participants
|
82 participants
n=107 Participants
|
157 participants
n=206 Participants
|
|
On aspirin
Yes
|
39 participants
n=99 Participants
|
32 participants
n=107 Participants
|
71 participants
n=206 Participants
|
|
On aspirin
No
|
44 participants
n=99 Participants
|
54 participants
n=107 Participants
|
98 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: d30Outcome measures
| Measure |
Early Invasive Strategy
n=83 Participants
Tirofiban and coronarography within six hours
|
Delayed Invasive Strategy
n=86 Participants
Coronarography after six hours
|
|---|---|---|
|
Mortality, Myocardial Infarction and Revascularization in Emergency
|
2 participants
|
21 participants
|
SECONDARY outcome
Timeframe: until the exit from the hospital and at d30.Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: d30Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: d30Outcome measures
Outcome data not reported
Adverse Events
Early Invasive Strategy
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Delayed Invasive Strategy
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Early Invasive Strategy
n=83 participants at risk
Tirofiban and coronarography within six hours
|
Delayed Invasive Strategy
n=86 participants at risk
Coronarography after six hours
|
|---|---|---|
|
General disorders
Major bleeding
|
2.4%
2/83 • 30 days
|
1.2%
1/86 • 30 days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place