Trial Outcomes & Findings for Is Verapamil In TransRadial Interventions OmittabLe? (NCT NCT01402427)
NCT ID: NCT01402427
Last Updated: 2014-06-02
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
591 participants
Primary outcome timeframe
Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.
Results posted on
2014-06-02
Participant Flow
Participant milestones
| Measure |
Verapamil
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Overall Study
STARTED
|
297
|
294
|
|
Overall Study
COMPLETED
|
297
|
294
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Is Verapamil In TransRadial Interventions OmittabLe?
Baseline characteristics by cohort
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
Total
n=591 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
62.1 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
186 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
376 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
297 participants
n=5 Participants
|
294 participants
n=7 Participants
|
591 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Occurrence of access site conversion will be assessed within 1 minute after completion of coronary angiography or intervention.Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Rate of Access Site Conversions
|
2 participants
|
5 participants
|
SECONDARY outcome
Timeframe: Occurrence of code breaking will be assessed within 1 minute after completion of coronary angiography or intervention.Code break: a composite of access site conversion and unplanned use of vasodilators.
Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Rate of Code Breaks
|
4 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Vasodilator use will be assessed within 1 minute after completion of coronary angiography or intervention.Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Rate of Vasodilator Use
|
297 participants
|
6 participants
|
SECONDARY outcome
Timeframe: Procedural time will be assessed within 1 minute after completion of coronary angiography or intervention.Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Procedural Time
|
17.0 minutes
Interval 10.0 to 31.0
|
16.0 minutes
Interval 9.0 to 30.0
|
SECONDARY outcome
Timeframe: Fluoroscopic time will be assessed within 1 minute after completion of coronary angiography or intervention.Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Fluoroscopic Time
|
4.8 minutes
Interval 2.4 to 10.7
|
4.4 minutes
Interval 2.1 to 9.6
|
SECONDARY outcome
Timeframe: The amount of contrast medium will be assessed within 1 minute after completion of coronary angiography or intervention.Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Contrast Volume
|
75.0 milliliter
Interval 47.0 to 156.5
|
72.5 milliliter
Interval 48.0 to 146.0
|
SECONDARY outcome
Timeframe: Subjective pain will be assessed within 1 minute after completion of coronary angiography or intervention.Analysis of the rates of significant pain defined as pain score ≥4 on a semiquantitative scale ranging from 1 to 6.
Outcome measures
| Measure |
Verapamil
n=297 Participants
Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
|
Placebo
n=294 Participants
Placebo: Intraarterial administration of 10 mL saline.
|
|---|---|---|
|
Subjective Pain
|
26 participants
|
21 participants
|
Adverse Events
Verapamil
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
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
Istvan Hizoh, MD, PhD / Senior Consultant
State Health Center, Hungary
Phone: +36 1 4651800
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place