High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion

High (100IU/Kg) Versus Standard (50IU/Kg) Heparin Dose for Prevention of Forearm Artery Occlusion Forearm Artery Occlusion

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).

Study Overview

• Status: Completed
• Conditions: Coronary Angiography
• Intervention / Treatment: Drug: Standard dose of Unfractionated heparin; Drug: High dose of Unfractionated Heparin

• Study Type: Interventional
• Enrollment (Actual): 1800
• Phase: Phase 4

Contacts and Locations

Study Locations

• Greece
  • Rion
    • Patras, Rion, Greece, 26500
      • Patras University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard dose of Heparin; 50IU/Kg heparin intravenously	Drug: Standard dose of Unfractionated heparin; Unfractionated heparin 50IU/Kg
Experimental: High dose of Heparin; 100IU/Kg heparin intravenously	Drug: High dose of Unfractionated Heparin; Unfractionated Heparin 100IU/Kg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radial artery occlusion	Radial artery occlusion as assessed by Doppler Ultrasound	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Large local hematomas of the forearm	large local hematomas of the forearm (defined as those extending beyond the forearm)	30 days
Major bleeding	≥ 5g/dL decrease in hemoglobin or ≥15% decrease in hematocrit or any life-threatening bleeding (confirmed by MRI or computed tomography)	30 days

Collaborators and Investigators

• Sponsor: University of Patras

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: October 5, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (Estimate): October 7, 2015

Study Record Updates

• Last Update Posted (Actual): September 19, 2017
• Last Update Submitted That Met QC Criteria: September 17, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: heparin; radial artery
• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin; Calcium heparin
• Other Study ID Numbers: PATRASCARDIOLOGY 20