CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 591 enrolled
Drug / intervention
Verapamil +1 moredrug
Likely dose
Verapamil 5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01402427
NCT01402427N/ACompleted

Omission of Prophylactic Verapamil Use in Transradial Coronary Interventions

State Health Center, Hungary·interventional·Posted Jul 26, 2011·Updated Jun 2, 2014

In Brief

A clinical study evaluating Verapamil and Placebo for Coronary Disease and Verapamil Toxicity. Completed, enrolled 591 participants across 1 site.

Detailed Summary

Background Verapamil is traditionally applied prophylactically in transradial procedures to prevent radial artery spasm. However, verapamil may have side effects and is contraindicated in some clinical settings. Methods: During an investigator-initiated, randomized, double-blind trial, we evaluate the need for preventive verapamil administration. After vascular access is established, patients receive either 5 mg verapamil (n=297) or placebo (n=294). We compare the rate of access site conversions as primary end point using a superiority margin of 5%. Occurrence of code breaks (composite of conversions and unplanned use of verapamil), overall verapamil use, procedural and fluoroscopic times, contrast volume, and subjective pain are investigated as secondary end points.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHungary
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 26, 2011
Enrollment StartMar 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 14.9 years ago

Interventions

Verapamildrug

Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.

Placebodrug

Intraarterial administration of 10 mL saline.