Verapamil vs Heparin in Transradial Procedures
VERMUT
Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
1 other identifier
interventional
418
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started May 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 27, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedOctober 4, 2016
October 1, 2016
1.3 years
May 13, 2015
October 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (5)
number of participants with each radial artery-related complication
24 hours
late radial artery occlusion
30 days
reopening early RAO
30 days
patient's satisfaction
24 hours
long term patient's satisfaction
30 days
Study Arms (2)
standard of care
ACTIVE COMPARATORintraradial heparin (5000 UI) immediately after a 6 F sheath insertion
experimental therapy
EXPERIMENTALintraradial verapamil (5 mg) immediately after a 6 F sheath insertion
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- warfarin therapy
- previous ipsilateral TRA
- lack of consent
- scleroderma
- thrombocytopenia
- or other contraindications to heparin
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Ferrara
Cona, Ferrara, 44124, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor and Interventional Cardiologist
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 27, 2015
Study Start
May 1, 2015
Primary Completion
August 1, 2016
Study Completion
September 1, 2016
Last Updated
October 4, 2016
Record last verified: 2016-10