Verapamil vs Heparin in Transradial Procedures
Information source: University Hospital of Ferrara
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Heart Disease, Ischemic
Intervention: Heparin (Drug); Verapamil (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: University Hospital of Ferrara Overall contact: Veronica Lodolini, BSc, Phone: +390532236450, Email: veronica.lodolini@student.unife.it
Summary
Transradial approach (TRA) for cardiac catheterization and percutaneous coronary
interventions (PCI) is increasingly being used worldwide. At the present is unknown the
cocktail of agents necessary to minimize local access site complications. The investigators
planned a prospective randomized clinical trial to test the superiority of verapamil vs.
heparin in the reduction of access site related complications.
Clinical Details
Official title: Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: number of participants with radial artery-related complications
Secondary outcome: number of participants with each radial artery-related complicationlate radial artery occlusion reopening early RAO patient's satisfaction long term patient's satisfaction
Detailed description:
Transradial approach (TRA) for cardiac catheterization and percutaneous coronary
interventions (PCI) is increasingly being used worldwide in both elective and emergency
procedures because it reduces net adverse clinical events, through a reduction in major
bleeding and all-cause mortality, when compared to transfemoral approach. However, radial
artery occlusion (RAO) after the procedure (the incidence of which varies from 1% to 10%)
remains one of the major limitations of TRA.
The aim of the study is to assess the superiority of verapamil versus heparin in the access
success during transradial percutaneous coronary interventions (PCI).
METHODS Patients referred to the cath-lab of the Cardiovascular Institute of the University
Hospital of Ferrara, Italy, for coronary angiography were randomized in 2 groups with a
computer-generated random sequence. The study is double-blind. In the first group, patients
received intravenous heparin (5000 UI) immediately after a 6 F sheath insertion. In the
second group, patients received Verapamil (5 mg) immediately after a 6 F sheath insertion.
If after the start of the procedure a radial artery spasm (RAS) occurs, the operators can
choose to use bail-out a local vasodilator therapy. After sheath removal, hemostasis was
obtained using a TR band (Terumo corporation, Tokyo, Japan) with a plethysmography-guided
patent hemostasis technique. Radial artery patency was evaluated at 24 hours (early RAO) and
30 days after the procedure (late RAO) by ultrasound.
The aim of the study is to demonstrate that verapamil administration is superior to heparin
administration in the reduction of the combined endpoint (occurrence of radial artery
occlusion (early RAO), access site complication, radial artery spasm (RAS) requiring local
bailout use of vasodilatator)
RAO will be assessed by ultrasonography by independent expert reviewer blinded to
randomization
The investigators defined access site complication the following items:
- local haematoma superficial <5 cm from access site;
- haematoma with moderate muscle infiltration <10 cm;
- forearm haematoma and muscular infiltration below the elbow;
- haematoma and muscular infiltration above the elbow;
- ischemic threat (compartmental syndrome);
- radial artery dissection during the procedure;
The investigators defined radial artery spasm any spasm occurring during the procedure
requiring the administration of local vasodilatators to allow the procedure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Patients admitted to hospital with diagnosis of acute coronary syndrome and stable
coronary artery disease according current European guidelines and with clinical indication
to coronary artery angiography.
- all patients receiving percutaneous coronary intervention by radial artery access as
first attempt
- procedures with 6F catheter
Exclusion Criteria:
- warfarin therapy
- previous ipsilateral TRA
- lack of consent
- scleroderma
- thrombocytopenia
- or other contraindications to heparin
Locations and Contacts
Veronica Lodolini, BSc, Phone: +390532236450, Email: veronica.lodolini@student.unife.it
University Hospital of Ferrara, Cona, Ferrara 44124, Italy; Recruiting Rita Pavasini, MD, Phone: +390532236450, Email: pvsrti@unife.it Silvia Punzetti, MD, Phone: +390532236450, Email: silvia.punz@gmail.com Gianluca Campo, MD, Principal Investigator Matteo Tebaldi, MD, Principal Investigator Carlo Tumscitz, MD, Sub-Investigator Simone Biscaglia, MD, Sub-Investigator
Additional Information
Starting date: May 2015
Last updated: May 21, 2015
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