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

University of Patras

Status and phase: Completed; Phase 4

Conditions: Coronary Angiography

Treatments: Drug: High dose of Unfractionated Heparin; Drug: Standard dose of Unfractionated heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT02570243

PATRASCARDIOLOGY 20

Details and patient eligibility

About

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).

Enrollment: 1,800 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,800 participants in 2 patient groups

Standard dose of Heparin

Active Comparator group

Description:

50IU/Kg heparin intravenously

Treatment:

Drug: Standard dose of Unfractionated heparin

High dose of Heparin

Experimental group

Description:

100IU/Kg heparin intravenously

Treatment:

Drug: High dose of Unfractionated Heparin