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Verapamil vs Heparin in Transradial Procedures (VERMUT)

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ClinicalTrials.gov Identifier: NCT02454491
Recruitment Status : Completed
First Posted : May 27, 2015
Last Update Posted : October 4, 2016
Sponsor:
Information provided by (Responsible Party):
Gianluca Campo, University Hospital of Ferrara

Tracking Information
First Submitted Date  ICMJE May 13, 2015
First Posted Date  ICMJE May 27, 2015
Last Update Posted Date October 4, 2016
Study Start Date  ICMJE May 2015
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
number of participants with radial artery-related complications [ Time Frame: 24 hours ]
occurrence of early radial artery occlusion, access site complication, radial artery spasm (RAS) that requires the bailout use of vasodilatator
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02454491 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2015)
  • number of participants with each radial artery-related complication [ Time Frame: 24 hours ]
    occurrence of each singular component of primary endpoint
  • late radial artery occlusion [ Time Frame: 30 days ]
    occurrence of radial artery occlusion (late RAO)
  • reopening early RAO [ Time Frame: 30 days ]
    reopening of the closed radial at 24 hours.
  • patient's satisfaction [ Time Frame: 24 hours ]
    assessment with questionnaires of the pain and satisfaction of patients
  • long term patient's satisfaction [ Time Frame: 30 days ]
    assessment with questionnaires of the pain and satisfaction of patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Verapamil vs Heparin in Transradial Procedures
Official Title  ICMJE Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Heart Disease, Ischemic
Intervention  ICMJE
  • Drug: Heparin
    intraradial administration of heparin 5000 ui
  • Drug: Verapamil
    intraradial administration of verapamil 5 mg
Study Arms  ICMJE
  • Active Comparator: standard of care
    intraradial heparin (5000 UI) immediately after a 6 F sheath insertion
    Intervention: Drug: Heparin
  • Experimental: experimental therapy
    intraradial verapamil (5 mg) immediately after a 6 F sheath insertion
    Intervention: Drug: Verapamil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 22, 2016)
418
Original Estimated Enrollment  ICMJE
 (submitted: May 21, 2015)
400
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02454491
Other Study ID Numbers  ICMJE 58
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gianluca Campo, University Hospital of Ferrara
Study Sponsor  ICMJE University Hospital of Ferrara
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University Hospital of Ferrara
Verification Date October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP