Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization (LOW-RAO)
Primary Purpose
Arterial Occlusion
Status
Completed
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
low molecular weight heparin
Sponsored by
About this trial
This is an interventional treatment trial for Arterial Occlusion focused on measuring radial artery occlusion, coronary catheterization, coronary artery disease, anticoagulation
Eligibility Criteria
Inclusion Criteria:
- Patients (both male and female) undergoing a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure.
- Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour)
Exclusion Criteria:
- Age < 18 years
- Unable to provide informed written consent
- Any contraindication to receive LMWH.
Sites / Locations
- 1st Cardiology Department, University General Hospital AHEPA
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Tinzaparin group
Control group
Arm Description
LMWH (tinzaparin) for 1 month (at body-weight-adjusted therapeutic dose)
No intervention
Outcomes
Primary Outcome Measures
Radial artery patency
To evaluate the effect of treatment with LMWH, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 1 month after the procedure, compared with no-LMWH treatment.
Secondary Outcome Measures
Bleeding events
To compare bleeding events (based on the BARC bleeding definition) at 1 month after the procedure between the LMWH and no-LMWH groups.
RAO incidence
To evaluate RAO incidence in coronary angiography and PCI groups.
Pain at the forearm
To compare incidence of pain at any region of the forearm at 1 month after the procedure between the LMWH and no-LMWH groups.
Full Information
NCT ID
NCT04196309
First Posted
November 25, 2019
Last Updated
July 28, 2021
Sponsor
AHEPA University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04196309
Brief Title
Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization
Acronym
LOW-RAO
Official Title
A Prospective, Randomized, Open-label Study to Evaluate the Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization Procedures
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
May 25, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AHEPA University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the LOW-RAO study is to determine the most effective treatment for radial artery occlusion (RAO) after transradial coronary catheterization (both angiography and PCI). This is a prospective, single-center, randomized controlled, open-label study that will randomize patients with RAO into two groups, one receiving anticoagulation with low-molecular-weight-heparin (LMWH) and the other receiving no anticoagulation. RAO will be detected by radial artery ultrasound up to 24 hours after the procedure.
Study objectives:
Primary objective:
a. To evaluate the effect of treatment with LMWH, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 1 month after the procedure, compared with no-LMWH treatment.
Secondary objectives:
To compare RAO as defined by different methods (pulse palpation, modified Allen's test, reverse Barbeau test, radial artery ultrasound).
To compare local access site and systemic complications (bleeding events, pseudoaneurysm, arteriovenous fistula) at 1 month after the procedure in the LMWH and no-LMWH groups.
To evaluate RAO incidence in coronary angiography and PCI groups.
To determine risk factors for RAO in coronary catheterization procedures.
Detailed Description
The use of the radial artery as an access site for coronary catheterization procedures, is constantly increasing because of lower rate of access site complications, shorter hospital stay, improved patient comfort and safe hemostasis. Radial artery occlusion remains a concern after transradial procedures, with a varied incidence, ranging from 5 to 38% as reported in the literature and probably reflecting different evaluation methods (pulse palpation versus ultrasound).
Although perceived as usually asymptomatic, registry data report that RAO may be symptomatic in up to 58.8% of patients, presenting as pain in the forearm, numbness/ paresthesia, paresis or acute ischemia. Moreover RAO excludes the affected vessel from future catheterization procedures, hemodialysis shunts, invasive hemodynamic monitoring, coronary arterial bypass grafting.
Spontaneous recanalization of the vessel after RAO ranges from 5.4 to 47% at 1-month follow up. Today there is no evidence-based therapy, in the frame of a randomized control study, for the treatment of RAO. Heparinization has been found to be effective in reducing the occurrence of radial artery occlusion and short-term treatment with low-molecular-weight heparin (LMWH) in symptomatic patients increases the patency rate of the radial artery after coronary catheterization procedures, without increasing bleeding complications, as depicted by registry data.
This is a prospective, randomized, multicenter study that will enroll, after informed written consent, all consecutive patients presenting with RAO, after a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure.
RAO will be diagnosed by radial artery ultrasound (2D, Doppler, colour) performed in all patients after sheath removal and successful local hemostasis and before hospital discharge. Clinical evaluation of radial artery patency with pulse palpation, modified Allen's test and reverse Barbeau test will be also applied in all patients.
Patients diagnosed with RAO will be randomized 1:1 into two groups:
Treatment group, that will receive LMWH (tinzaparin) for 1 month (at body-weight-adjusted therapeutic dose).
Control group, that will not receive additional LMWH. All asymptomatic patients, with patent radial artery at initial work-up, will be provided with the opportunity to return to the center for further evaluation, clinically and by ultrasound, if they become symptomatic at any time after hospital discharge, in order to diagnose late RAO.
They will also be provided with the opportunity to be randomized to LMWH or not in case RAO is diagnosed and after informed written consent.
Patients already on anticoagulation for any other reason will neither be excluded nor randomized, but will be followed-up as the randomized ones, in order to collect data from this patient population.
All patients with RAO will be re-evaluated by radial artery ultrasound at 1-, 2- 4- weeks to determine radial artery patency and record any bleeding complications according to the EASY (Early Discharge After Transradial Stenting of Coronary Arteries) Hematoma Classification and the BARC (Bleeding Academic Research Consortium) bleeding definition.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusion
Keywords
radial artery occlusion, coronary catheterization, coronary artery disease, anticoagulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tinzaparin group
Arm Type
Experimental
Arm Description
LMWH (tinzaparin) for 1 month (at body-weight-adjusted therapeutic dose)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Drug
Intervention Name(s)
low molecular weight heparin
Intervention Description
LMWH (tinzaparin) at body-weight-adjusted therapeutic dose (175 anti-Xa IU/kg subcutaneously once daily)
Primary Outcome Measure Information:
Title
Radial artery patency
Description
To evaluate the effect of treatment with LMWH, in patients (both symptomatic and asymptomatic) with RAO after a coronary catheterization procedure (both angiography and percutaneous coronary intervention-PCI), in improving patency rates of the radial artery at 1 month after the procedure, compared with no-LMWH treatment.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Bleeding events
Description
To compare bleeding events (based on the BARC bleeding definition) at 1 month after the procedure between the LMWH and no-LMWH groups.
Time Frame
1 month
Title
RAO incidence
Description
To evaluate RAO incidence in coronary angiography and PCI groups.
Time Frame
24 hours
Title
Pain at the forearm
Description
To compare incidence of pain at any region of the forearm at 1 month after the procedure between the LMWH and no-LMWH groups.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients (both male and female) undergoing a coronary catheterization procedure (both angiography and PCI) through the transradial access and having successfully received at least one radial artery sheath of any size at the end of the procedure.
Radial artery occlusion confirmed by ultrasound (2D, Doppler, colour)
Exclusion Criteria:
Age < 18 years
Unable to provide informed written consent
Any contraindication to receive LMWH.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antonios Ziakas, MD, PhD
Organizational Affiliation
1st Cardiology Department, University General Hospital AHEPA, Thessaloniki
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Matthaios V. Didagelos, MD
Organizational Affiliation
1st Cardiology Department, University General Hospital AHEPA, Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
1st Cardiology Department, University General Hospital AHEPA
City
Thessaloníki
ZIP/Postal Code
54636
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34397270
Citation
Didagelos M, Pagiantza A, Zegkos T, Papanastasiou C, Zarra K, Angelopoulos V, Kouparanis A, Peteinidou E, Sianos G, Karvounis H, Ziakas A. Low-molecular-weight heparin in radial artery occlusion treatment: the LOW-RAO randomized study. Future Cardiol. 2022 Feb;18(2):91-100. doi: 10.2217/fca-2021-0067. Epub 2021 Aug 16.
Results Reference
derived
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Effect of LOW-molecular-weight Heparin in Reducing Radial Artery Occlusion Rate After Transradial Coronary Catheterization
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