Verapamil vs Heparin in Transradial Procedures

NCT ID: NCT02454491

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2016-09-30

Brief 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.

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

Conditions

Heart Disease, Ischemic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

standard of care

intraradial heparin (5000 UI) immediately after a 6 F sheath insertion

Group Type: ACTIVE_COMPARATOR

Heparin

Intervention Type: DRUG

intraradial administration of heparin 5000 ui

experimental therapy

intraradial verapamil (5 mg) immediately after a 6 F sheath insertion

Group Type: EXPERIMENTAL

Verapamil

Intervention Type: DRUG

intraradial administration of verapamil 5 mg

Interventions

Heparin

intraradial administration of heparin 5000 ui

Intervention Type: DRUG

Verapamil

intraradial administration of verapamil 5 mg

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of Ferrara

OTHER

Sponsor Role: lead

Responsible Party

Gianluca Campo

Assistant Professor and Interventional Cardiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of Ferrara

Cona, Ferrara, Italy

Countries

Italy

Other Identifiers

58

Identifier Type: -

Identifier Source: org_study_id