NCT04196309

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:

  1. 1.Primary objective:
  2. 2.Secondary objectives:
  3. 3.To compare RAO as defined by different methods (pulse palpation, modified Allen's test, reverse Barbeau test, radial artery ultrasound).
  4. 4.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.
  5. 5.To evaluate RAO incidence in coronary angiography and PCI groups.
  6. 6.To determine risk factors for RAO in coronary catheterization procedures.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2017

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 12, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

July 30, 2021

Status Verified

July 1, 2021

Enrollment Period

3.6 years

First QC Date

November 25, 2019

Last Update Submit

July 28, 2021

Conditions

Arterial Occlusion

Keywords

radial artery occlusioncoronary catheterizationcoronary artery diseaseanticoagulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 month

Secondary Outcomes (3)

  • Bleeding events

    1 month

  • RAO incidence

    24 hours

  • Pain at the forearm

    1 month

Study Arms (2)

Tinzaparin group

EXPERIMENTAL

LMWH (tinzaparin) for 1 month (at body-weight-adjusted therapeutic dose)

Drug: low molecular weight heparin

Control group

NO INTERVENTION

No intervention

Interventions

low molecular weight heparinDRUG

LMWH (tinzaparin) at body-weight-adjusted therapeutic dose (175 anti-Xa IU/kg subcutaneously once daily)

Tinzaparin group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Age \< 18 years
  • Unable to provide informed written consent
  • Any contraindication to receive LMWH.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1st Cardiology Department, University General Hospital AHEPA

Thessaloniki, 54636, Greece

Location

Related Publications (1)

  • 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.

    PMID: 34397270DERIVED

MeSH Terms

Conditions

Arterial Occlusive DiseasesCoronary Artery Disease

Interventions

Heparin, Low-Molecular-Weight

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesCoronary DiseaseMyocardial IschemiaHeart DiseasesArteriosclerosis

Intervention Hierarchy (Ancestors)

HeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Antonios Ziakas, MD, PhD

    1st Cardiology Department, University General Hospital AHEPA, Thessaloniki

    PRINCIPAL INVESTIGATOR

  • Matthaios V. Didagelos, MD

    1st Cardiology Department, University General Hospital AHEPA, Thessaloniki

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Principal Investigator

Study Record Dates

First Submitted

November 25, 2019

First Posted

December 12, 2019

Study Start

May 25, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

July 30, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

GR(1)