Actively Recruiting
Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
Led by University Hospital, Strasbourg, France · Updated on 2026-05-26
550
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the timing of anticoagulant (heparin) administration during percutaneous coronary intervention (PCI) performed via radial artery access. Radial artery occlusion is a common complication after this procedure, occurring in up to 30% of patients, and anticoagulation is recommended to reduce this risk. This study aims to compare whether giving heparin before sheath insertion versus after sheath insertion affects the rate of radial artery occlusion. The trial is a single-center, randomized, single-blind study with blinded evaluation of outcomes. Participants will be randomly assigned to one of two groups: one group will receive heparin injection before sheath insertion (early injection), and the other will receive heparin after sheath insertion (delayed injection). The heparin dose is standardized at 50 IU/kg. The PCI will be performed according to standard practice using radial access. Hemostasis after the procedure will be managed with a mechanical compression device. Adjustments to heparin dosing may be made if additional angioplasty is performed. Patients will be followed up for 30 days to monitor for complications. Participants will undergo clinical evaluations including interviews, physical exams, and Doppler ultrasound of the upper limb artery on day 1 after the procedure. Follow-up phone interviews at day 30 will check for symptoms of radial occlusion or major cardiovascular events. The primary outcome is the rate of radial artery occlusion at day 1, determined by Doppler ultrasound. Secondary outcomes include symptomatic occlusion, bleeding events, major cardiovascular events, puncture failure, functional impact, and mortality at day 30. The total participation duration is approximately one month.
CONDITIONS
Brief Title
Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older undergoing percutaneous radial coronary intervention
- Affiliated with a social protection health insurance
- Able to understand the study's objectives and risks
- Able to provide dated and signed informed consent
- Informed of preliminary medical examination results
You will not qualify if you...
- Contraindication to heparin use (history of heparin-induced thrombocytopenia)
- Very high bleeding risk defined by recent major bleeding (<6 months) per BARC type 3
- Currently in an exclusion period from another study
- Inability to understand or provide informed consent (emergency, comprehension difficulties)
- Under legal protection (guardianship, curatorship, or safeguard of justice)
- Pregnant or breastfeeding
- Currently on anticoagulant treatments such as anti-vitamin K or direct oral anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for consent and eligibility verification
Duration - Day 0 (procedure day)
Participants undergo percutaneous coronary intervention via radial access with anticoagulant administration either before or after sheath insertion as per randomization.
1 in-person visit for the procedure and immediate post-procedure care
Duration - 1 day
Participants receive clinical examination and upper limb arterial Doppler ultrasound on the day after the procedure to assess radial artery status and complications.
1 in-person visit on Day 1
Duration - Day 30 (±7 days)
Participants are contacted by phone to assess symptoms of radial occlusion, cardiovascular events, and other outcomes with possible additional consultation if symptoms are reported.
1 telephone interview with potential additional in-person consultation if needed
Trial Site Locations
Total: 1 location
1
Hôpitaux Universitaires de Strasbourg
Strasbourg, Bas-Rhin, France, 67091
Actively Recruiting
Research Team
P
Pr Patrick OHLMANN Pr Patrick OHLMANN, Professor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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