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

NCT ID: NCT02570243

Last Updated: 2017-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-09-30

Brief Summary

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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).

Detailed Description

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Conditions

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Coronary Angiography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard dose of Heparin

50IU/Kg heparin intravenously

Group Type ACTIVE_COMPARATOR

Standard dose of Unfractionated heparin

Intervention Type DRUG

Unfractionated heparin 50IU/Kg

High dose of Heparin

100IU/Kg heparin intravenously

Group Type EXPERIMENTAL

High dose of Unfractionated Heparin

Intervention Type DRUG

Unfractionated Heparin 100IU/Kg

Interventions

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High dose of Unfractionated Heparin

Unfractionated Heparin 100IU/Kg

Intervention Type DRUG

Standard dose of Unfractionated heparin

Unfractionated heparin 50IU/Kg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Patras

OTHER

Sponsor Role lead

Responsible Party

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Dimitrios Alexopoulos

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Patras University Hospital

Pátrai, Rion, Greece

Site Status

Countries

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Greece

References

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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.

Reference Type DERIVED
PMID: 30391389 (View on PubMed)

Other Identifiers

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PATRASCARDIOLOGY 20

Identifier Type: -

Identifier Source: org_study_id