Conditions: Coronary Disease Verapamil Toxicity
Keywords: Coronary Artery Disease Coronary Angiography Percutaneous Coronary Intervention Transradial Radial Artery Spasm Verapamil Adverse Effects
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 591
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Verapamil intervention 2: Placebo
Intervention descriptions: intervention 1: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL. intervention 2: Intraarterial administration of 10 mL saline.

Protocol document: