NCT02570243

Brief Summary

This is a prospective, multi-center, superiority study of parallel design. Patients are enrolled if they are older than 18 years old, are scheduled for 5 or 6 Fr diagnostic coronary angiography and the interventional cardiologist is willing to proceed with radial access. Patients are randomized before diagnostic catheterization to receive intravenously either 100IU/Kg or 50 IU/Kg of unfractionated heparin (UFH) in a 1:1 ratio. Patients are discharged usually within 4 to 6 hours after coronary angiography. Radial artery in each patient is evaluated either in-hospital or during a subsequent visit by one physician who is blinded to the actual antithrombotic treatment given. Radial artery is considered occluded if it exhibits ultrasonographically no antegrade flow signal both at baseline and after reevaluation on a second occasion, within 30 days after the index procedure. Initially patent arteries will not be reexamined and are thought to remain permanently patent. The investigators also monitor major bleeding (defined as ≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography) and large local hematomas of the forearm (defined as those extending beyond the forearm).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2015

Typical duration 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

February 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 7, 2015

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

2.6 years

First QC Date

October 5, 2015

Last Update Submit

September 17, 2017

Conditions

Coronary Angiography

Keywords

heparinradial artery

Outcome Measures

Primary Outcomes (1)

  • Radial artery occlusion

    Radial artery occlusion as assessed by Doppler Ultrasound

    30 days

Secondary Outcomes (2)

  • Large local hematomas of the forearm

    30 days

  • Major bleeding

    30 days

Study Arms (2)

Standard dose of Heparin

ACTIVE COMPARATOR

50IU/Kg heparin intravenously

Drug: Standard dose of Unfractionated heparin

High dose of Heparin

EXPERIMENTAL

100IU/Kg heparin intravenously

Drug: High dose of Unfractionated Heparin

Interventions

High dose of Unfractionated HeparinDRUG

Unfractionated Heparin 100IU/Kg

High dose of Heparin
Standard dose of Unfractionated heparinDRUG

Unfractionated heparin 50IU/Kg

Standard dose of Heparin

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years old
  • Scheduled for 5 or 6 Fr diagnostic coronary angiography
  • The interventional cardiologist is willing to proceed with radial access
  • Written informed consent

You may not qualify if:

  • Before randomization
  • chronic hemodialysis
  • oral anticoagulation
  • hemodynamic instability
  • severe dermo-myoskeletal forearm deformities
  • history of CABG and bilateral use of either the internal mammary or radial artery
  • history of CABG and ipsilateral use of both the internal mammary and radial artery
  • admission for elective PCI After randomization
  • crossover to another arterial access site is required
  • ad hoc PCI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patras University Hospital

Pátrai, Rion, 26500, Greece

Location

Related Publications (1)

  • Hahalis GN, Leopoulou M, Tsigkas G, Xanthopoulou I, Patsilinakos S, Patsourakos NG, Ziakas A, Kafkas N, Koutouzis M, Tsiafoutis I, Athanasiadis I, Koniari I, Almpanis G, Anastasopoulou M, Despotopoulos S, Kounis N, Dapergola A, Aznaouridis K, Davlouros P. Multicenter Randomized Evaluation of High Versus Standard Heparin Dose on Incident Radial Arterial Occlusion After Transradial Coronary Angiography: The SPIRIT OF ARTEMIS Study. JACC Cardiovasc Interv. 2018 Nov 26;11(22):2241-2250. doi: 10.1016/j.jcin.2018.08.009. Epub 2018 Nov 1.

    PMID: 30391389DERIVED

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiology

Study Record Dates

First Submitted

October 5, 2015

First Posted

October 7, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

GR(1)