Trial Outcomes & Findings for A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks (NCT NCT00719914)
NCT ID: NCT00719914
Last Updated: 2012-08-27
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
31 participants
Primary outcome timeframe
30 days
Results posted on
2012-08-27
Participant Flow
Participant milestones
| Measure |
Additional Bolus of Eptifibatide
Intracoronary injection of eptifibatide
|
Bolus of Normal Saline
Intracoronary injection of normal saline.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
7
|
|
Overall Study
COMPLETED
|
10
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Safety/Efficacy Study of Intracoronary Integrilin to Improve Balloon Angioplasty Outcomes for the Treatment of Heart Attacks
Baseline characteristics by cohort
| Measure |
Additional Bolus of Eptifibatide
n=10 Participants
Intracoronary injection of eptifibatide
|
Bolus of Normal Saline
n=7 Participants
Intra-coronary injection of normal saline.
|
Total
n=17 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
57.9 years
STANDARD_DEVIATION 10.2 • n=5 Participants
|
67 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
61.6 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Age, Customized
<=18 years
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Age, Customized
Between 18 and 75 years
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Age, Customized
>=75 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
7 participants
n=7 Participants
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 daysPopulation: study terminated due to low enrollment
Outcome measures
Outcome data not reported
Adverse Events
Additional Bolus of Eptifibatide
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Bolus of Normal Saline
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place