Is Verapamil In TransRadial Interventions OmittabLe? (VITRIOL)

State Health Center, Hungary

Status: Completed

Conditions: Verapamil Toxicity; Coronary Disease

Treatments: Drug: Placebo; Drug: Verapamil

Study type: Interventional

Funder types: Other

Identifiers

NCT01402427

SHCCARD-001

Details and patient eligibility

About

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.

Enrollment: 591 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients undergoing transradial coronary angiography and/or percutaneous coronary intervention
• successful cannulation of the radial artery

Exclusion criteria

• reduced left ventricular systolic function (LVEF<35%)
• significant aortic stenosis
• bradycardia (<50/min.)
• myocardial infarction complicated by cardiogenic shock and/or high grade AV block

Trial design

591 participants in 2 patient groups, including a placebo group

Verapamil

Active Comparator group

Treatment:

Drug: Verapamil

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo