Verapamil vs Heparin in Transradial Procedures (VERMUT)
Primary Purpose
Heart Disease, Ischemic
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
Heparin
Verapamil
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease, Ischemic focused on measuring percutaneous coronary interventions, radial artery access, access site complications, verapamil, heparin
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
Sites / Locations
- University Hospital of Ferrara
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
standard of care
experimental therapy
Arm Description
intraradial heparin (5000 UI) immediately after a 6 F sheath insertion
intraradial verapamil (5 mg) immediately after a 6 F sheath insertion
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
number of participants with each radial artery-related complication
occurrence of each singular component of primary endpoint
late radial artery occlusion
occurrence of radial artery occlusion (late RAO)
reopening early RAO
reopening of the closed radial at 24 hours.
patient's satisfaction
assessment with questionnaires of the pain and satisfaction of patients
long term patient's satisfaction
assessment with questionnaires of the pain and satisfaction of patients
Full Information
NCT ID
NCT02454491
First Posted
May 13, 2015
Last Updated
October 1, 2016
Sponsor
University Hospital of Ferrara
1. Study Identification
Unique Protocol Identification Number
NCT02454491
Brief Title
Verapamil vs Heparin in Transradial Procedures
Acronym
VERMUT
Official Title
Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
May 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital of Ferrara
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Ischemic
Keywords
percutaneous coronary interventions, radial artery access, access site complications, verapamil, heparin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
418 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard of care
Arm Type
Active Comparator
Arm Description
intraradial heparin (5000 UI) immediately after a 6 F sheath insertion
Arm Title
experimental therapy
Arm Type
Experimental
Arm Description
intraradial verapamil (5 mg) immediately after a 6 F sheath insertion
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
intraradial administration of heparin 5000 ui
Intervention Type
Drug
Intervention Name(s)
Verapamil
Intervention Description
intraradial administration of verapamil 5 mg
Primary Outcome Measure Information:
Title
number of participants with radial artery-related complications
Description
occurrence of early radial artery occlusion, access site complication, radial artery spasm (RAS) that requires the bailout use of vasodilatator
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
number of participants with each radial artery-related complication
Description
occurrence of each singular component of primary endpoint
Time Frame
24 hours
Title
late radial artery occlusion
Description
occurrence of radial artery occlusion (late RAO)
Time Frame
30 days
Title
reopening early RAO
Description
reopening of the closed radial at 24 hours.
Time Frame
30 days
Title
patient's satisfaction
Description
assessment with questionnaires of the pain and satisfaction of patients
Time Frame
24 hours
Title
long term patient's satisfaction
Description
assessment with questionnaires of the pain and satisfaction of patients
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Hospital of Ferrara
City
Cona
State/Province
Ferrara
ZIP/Postal Code
44124
Country
Italy
12. IPD Sharing Statement
Learn more about this trial
Verapamil vs Heparin in Transradial Procedures
We'll reach out to this number within 24 hrs