Best timing for heparin during radial-access coronary procedures
Timing of Anticoagulant Administration During Radial Access Percutaneous Coronary Intervention: the HERA-PCI Study (Heparin Early for Radial Access Percutaneous Coronary Intervention)
This research will test whether giving heparin before inserting the radial sheath instead of after lowers the chance of radial artery occlusion in adults having radial-access coronary angiography or PCI.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 550 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France Academic / other |
| Locations | 1 site (Strasbourg, Bas-Rhin) |
| Trial ID | NCT06890312 on ClinicalTrials.gov |
What this trial studies
This randomized interventional study will assign adults undergoing radial-access coronary angiography or percutaneous coronary intervention to receive unfractionated heparin either before radial sheath insertion or after sheath insertion. The trial will compare rates of radial artery occlusion and monitor for bleeding events and other procedural complications. Most centers routinely use unfractionated heparin during radial procedures, but no prior study has examined whether timing around sheath insertion changes outcomes. The study is conducted at Hôpitaux Universitaires de Strasbourg and enrolls patients able to consent who are not on chronic anticoagulation and have no contraindication to heparin.
Who should consider this trial
Good fit: Adults (≥18) undergoing radial-access coronary angiography or PCI who can provide informed consent and are not on chronic oral anticoagulants or contraindicated to heparin.
Not a fit: Patients on chronic anticoagulant therapy, with a contraindication to heparin, very high bleeding risk, pregnancy, or breastfeeding are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, earlier heparin administration could lower radial artery occlusion rates and help preserve the artery for future procedures.
How similar studies have performed: Prior studies show that systemic anticoagulation and higher heparin doses reduce radial artery occlusion, but the specific question of timing relative to sheath insertion is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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.) * Subject under safeguard of justice * Subject under guardianship or curatorship * Pregnancy * Breastfeeding * Patient on anticoagulant treatment: anti-vitamin K, direct oral anticoagulants (DOACs).
Where this trial is running
Strasbourg, Bas-Rhin
- Hôpitaux Universitaires de Strasbourg — Strasbourg, Bas-Rhin, France (Recruiting)
Study contacts
- Study coordinator: Pr Patrick OHLMANN Pr Patrick OHLMANN, Professor
- Email: patrick.ohlmann@chru-strasbourg.fr
- Phone: 03.69.55.09.53
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.