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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

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.

Condition or disease Intervention/treatment Phase
Heart Disease, Ischemic Drug: Heparin Drug: Verapamil Phase 4

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
Study Start Date : May 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Arm Intervention/treatment
Active Comparator: standard of care
intraradial heparin (5000 UI) immediately after a 6 F sheath insertion
Drug: Heparin
intraradial administration of heparin 5000 ui

Experimental: experimental therapy
intraradial verapamil (5 mg) immediately after a 6 F sheath insertion
Drug: Verapamil
intraradial administration of verapamil 5 mg




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. number of participants with each radial artery-related complication [ Time Frame: 24 hours ]
    occurrence of each singular component of primary endpoint

  2. late radial artery occlusion [ Time Frame: 30 days ]
    occurrence of radial artery occlusion (late RAO)

  3. reopening early RAO [ Time Frame: 30 days ]
    reopening of the closed radial at 24 hours.

  4. patient's satisfaction [ Time Frame: 24 hours ]
    assessment with questionnaires of the pain and satisfaction of patients

  5. long term patient's satisfaction [ Time Frame: 30 days ]
    assessment with questionnaires of the pain and satisfaction of patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02454491


Locations
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Italy
University Hospital of Ferrara
Cona, Ferrara, Italy, 44124
Sponsors and Collaborators
University Hospital of Ferrara

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Responsible Party: Gianluca Campo, Assistant Professor and Interventional Cardiologist, University Hospital of Ferrara
ClinicalTrials.gov Identifier: NCT02454491     History of Changes
Other Study ID Numbers: 58
First Posted: May 27, 2015    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016
Keywords provided by Gianluca Campo, University Hospital of Ferrara:
percutaneous coronary interventions
radial artery access
access site complications
verapamil
heparin
Additional relevant MeSH terms:
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Heart Diseases
Heparin
Calcium heparin
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Verapamil
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents