Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)

NCT06890312 | Recruiting

• 1 other identifier: 9323
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

While the reduced hemorrhagic risk of radial access for percutaneous coronary intervention compared to femoral access is well-established, its main complication remains radial artery occlusion, which can occur in up to 30% of patients. Anticoagulation is the primary preventive measure recommended in clinical practice to reduce the risk of this complication, typically involving heparin injection during the procedure in most centers. However, data on the effect of the timing of heparin injection are limited. The investigators hypothesize that injection of heparin before sheath insertion may reduce the rate of radial artery occlusion compared with injection after sheath insertion.

Conditions

Coronary Angiography; Percutaneous Coronary Intervention; Radial Artery Occlusion; Bleeding; Anticoagulation

Keywords

Anticoagulant injection timing; Percutaneous coronary intervention; Coronary angiography; Radial artery occlusion prevention; Bleeding events

Outcome Measures

Primary Outcomes (1)

• Rate of radial artery occlusion

  The primary endpoint is the rate of radial artery occlusion, as determined by Doppler ultrasound at day 1.

  Day 1

Secondary Outcomes (5)

• Rate of symptomatic radial artery occlusion (acute hand ischemia) on day 1

  Day1

• Major cardiovascular events within the first 30 days following the percutaneous coronary intervention: cardiovascular death, myocardial infarction, and stroke.

  Day 30

• Local and general hemorrhagic events

  Day 30

• Rate of radial puncture failure.

  Day 0

• Rate of all-cause mortality on day 30.

  Day 30

Study Arms (2)

"heparin delayed injection"

ACTIVE COMPARATOR

Administration of heparin after sheath insertion

Procedure: Administration of heparin after sheath insertion

heparin early injection

EXPERIMENTAL

Administration of heparin prior to sheath insertion

Procedure: Administration of heparin prior to sheath insertion

Interventions

Administration of heparin after sheath insertion PROCEDURE

Administration of heparin after sheath insertion

"heparin delayed injection"

Administration of heparin prior to sheath insertion PROCEDURE

Administration of heparin prior to sheath insertion

heparin early injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having 18 years old or older, regardless of gender, undergoing percutaneous radial coronary intervention
• Subject affiliated to a social protection health insurance
• Subject able to understand the objectives and risks of the research and to provide dated and signed consent
• Subject who has been informed of the results of the preliminary medical examination

You may not qualify if:

• Contraindication to the use of heparin (history of heparin-induced thrombocytopenia)
• Very high bleeding risk defined by recent bleeding (\<6 months) of type 3 of the BARC classification
• Inability to give the subject enlightened information (subject in an emergency situation, difficulties in understanding the subject, etc.)
• Subject under safeguard of justice
• Subject under guardianship or curatorship
• Pregnancy
• Breastfeeding
• Patient on anticoagulant treatment: anti-vitamin K, direct oral anticoagulants (DOACs).

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, Bas-Rhin, 67091, France

RECRUITING

MeSH Terms

Conditions

Arterial Occlusive Diseases; Hemorrhage

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pr Patrick OHLMANN Pr Patrick OHLMANN, Professor

CONTACT

03.69.55.09.53; patrick.ohlmann@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: March 24, 2025
• Study Start: June 5, 2025
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)