Verapamil vs Heparin in Transradial Procedures

Heart Disease, Ischemic Clinical Trial

— VERMUT  

Official title:

Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02454491
• Other study ID #: 58
• Status: Completed
• Phase: Phase 4
• First received: May 13, 2015
• Last updated: October 1, 2016
• Start date: May 2015
• Est. completion date: September 2016

Study information

• Verified date: October 2016
• Source: University Hospital of Ferrara
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease, Ischemic
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• Heparin
intraradial administration of heparin 5000 ui
• Verapamil
intraradial administration of verapamil 5 mg

Locations

Country	Name	City	State
Italy	University Hospital of Ferrara	Cona	Ferrara

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with radial artery-related complications	occurrence of early radial artery occlusion, access site complication, radial artery spasm (RAS) that requires the bailout use of vasodilatator	24 hours	No
Secondary	number of participants with each radial artery-related complication	occurrence of each singular component of primary endpoint	24 hours	No
Secondary	late radial artery occlusion	occurrence of radial artery occlusion (late RAO)	30 days	No
Secondary	reopening early RAO	reopening of the closed radial at 24 hours.	30 days	No
Secondary	patient's satisfaction	assessment with questionnaires of the pain and satisfaction of patients	24 hours	No
Secondary	long term patient's satisfaction	assessment with questionnaires of the pain and satisfaction of patients	30 days	No