Heart Disease, IschemicPhase 4VERMUTNCT02454491
Verapamil vs Heparin in Transradial Procedures
A Phase 4 study testing Heparin and Verapamil in people with Heart Disease, Ischemic, run by University Hospital of Ferrara at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Disease, Ischemic
- What is being tested?
- Heparin and Verapamil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 418 participants
- Where
- 1 siteItaly
- Study dates
- May 2015to Sep 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- warfarin therapy
- previous ipsilateral TRA
- lack of consent
- scleroderma
- thrombocytopenia
- or other contraindications to heparin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
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.
Read the 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
- Being tested
- Heparin, Verapamil
- Keywords
- percutaneous coronary interventions, radial artery access, access site complications, verapamil, heparin
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
intraradial administration of heparin 5000 ui
VerapamilDrug
intraradial administration of verapamil 5 mg
| Study group | Role | What they receive |
|---|---|---|
| standard of care | Active comparator | intraradial heparin (5000 UI) immediately after a 6 F sheath insertion Receives: Drug: Heparin |
| experimental therapy | Experimental | intraradial verapamil (5 mg) immediately after a 6 F sheath insertion Receives: Drug: Verapamil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 hours
Secondary outcomes (5)
number of participants with each radial artery-related complication
occurrence of each singular component of primary endpoint
Measured: 24 hours
late radial artery occlusion
occurrence of radial artery occlusion (late RAO)
Measured: 30 days
reopening early RAO
reopening of the closed radial at 24 hours.
Measured: 30 days
patient's satisfaction
assessment with questionnaires of the pain and satisfaction of patients
Measured: 24 hours
long term patient's satisfaction
assessment with questionnaires of the pain and satisfaction of patients
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2015 (estimated)
- Study startMay 2015
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Disease, IschemicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 418 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Ferrara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Campo, University Hospital of Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02454491
- Sponsor's protocol ID
- 58
- Acronym
- VERMUT
- Status last verified
- Oct 2016
- First submitted
- 13 May 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of VERapamil vs. Heparin Therapy on Procedural sUccess During Transradial Coronary Procedures (VERMUT Study)
- ClinicalTrials.gov ID
- NCT02454491
- Acronym / sponsor ID
- VERMUT / 58
- Conditions
- Heart Disease, Ischemic
- Keywords
- percutaneous coronary interventions, radial artery access, access site complications, verapamil, heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 418 participants (actual)
- Lead sponsor
- University Hospital of FerraraUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 27 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | Active comparator | Drug: Heparinintraradial heparin (5000 UI) immediately after a 6 F sheath insertion |
| experimental therapy | Experimental | Drug: Verapamilintraradial verapamil (5 mg) immediately after a 6 F sheath insertion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- warfarin therapy
- previous ipsilateral TRA
- lack of consent
- scleroderma
- thrombocytopenia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heparinintraradial administration of heparin 5000 ui | Drug | standard of care |
| Verapamilintraradial administration of verapamil 5 mg | Drug | experimental therapy |
Primary outcome
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
5 secondary outcomes
number of participants with each radial artery-related complication
Time frame: 24 hours
late radial artery occlusion
Time frame: 30 days
reopening early RAO
Time frame: 30 days
patient's satisfaction
Time frame: 24 hours
long term patient's satisfaction
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Heparin and Verapamil in people with Heart Disease, Ischemic, run by University Hospital of Ferrara at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with radial artery-related complications (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2016.