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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Subject in an exclusion period (determined by a previous or ongoing study)

Inability to give the subject enlightened information (subject in an emergency situation, difficulties in understanding the subject, etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Administration of heparin after sheath insertion

    Procedure/Surgery

    Administration of heparin after sheath insertion

  • Administration of heparin prior to sheath insertion

    Procedure/Surgery

    Administration of heparin prior to sheath insertion

Treatment groups

550 Participants
are divided into 2 treatment groups
Group A: "heparin delayed injection"Active comparator 1 intervention
Group B: heparin early injectionExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
Day 1

Secondary outcomes

1

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

The rate of symptomatic radial artery occlusion (acute hand ischemia) on day 1. The rate of occlusion will be assessed through a thorough clinical examination on day 1 after the procedure, and if necessary, based on clinical findings, by an upper limb CT angiography. A telephone interview will also be conducted on day 30 to check for symptoms of symptomatic radial artery occlusion (signs of hand ischemia). If symptoms are present, the patient will be scheduled for a consultation with arterial Doppler ultrasound to confirm or rule out radial occlusion.

Time frame
Day1
2

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

Major cardiovascular events within the first 30 days following the percutaneous coronary intervention: cardiovascular death, myocardial infarction, and stroke. These events will be assessed during the visits on day 1 and day 30

Time frame
Day 30
3

Local and general hemorrhagic events

Local functional impact evaluated on day 30 by the presence of residual pain in the radial region or limited joint mobility.

Time frame
Day 30
4

Rate of radial puncture failure.

The rate of radial puncture failure.

Time frame
Day 0

Other outcomes

Sponsors and contacts

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