All studies
RecruitingNAINTERVENTIONAL

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

This study, called HERA-PCI, is all about improving a common heart procedure called Percutaneous Coronary Intervention (PCI). When doctors do PCI through a blood vessel in your wrist (radial access), there's a chance that artery might get blocked afterwards. To prevent this, patients usually receive a blood-thinning medicine called heparin. Doctors aren't sure if it's better to give this medicine a little earlier, before a small tube (sheath) is put into the wrist, or if it's fine to give it after. This study aims to find out which timing works best to reduce the risk of the wrist artery blocking, helping to make the procedure even safer for patients.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital, Strasbourg, France
Enrolment target
550
Start
05 Jun 2025
Estimated completion
01 Jan 2028

What is this study about?

Heart procedures, like Percutaneous Coronary Intervention (PCI), are often done by putting a thin tube into an artery in your wrist. This method is usually preferred because it means less bleeding compared to using an artery in your leg. However, sometimes the wrist artery can get blocked afterward – this is called radial artery occlusion. It's a common problem, affecting up to 3 out of every 10 patients.

To help prevent this blocking, patients are given a blood-thinning medicine, usually heparin, during the procedure. What doctors don't know for sure is the best time to give this medicine. Some doctors give it before they put a small tube (called a sheath) into the wrist, while others give it after the sheath is already in place. The main idea behind this study is that giving the heparin a bit earlier, before the sheath fully occupies the artery, might allow the medicine to work better at preventing a blockage.

This study will compare both timings to see if one is clearly better at keeping the wrist artery open. Finding the optimal timing could make this common and important heart procedure even safer and more effective for many people. It's about fine-tuning current practices based on solid evidence to improve patient outcomes.

Key takeaways

  • Study compares two timings for giving blood-thinner (heparin) during a heart procedure through the wrist.
  • Goal is to reduce the risk of the wrist artery getting blocked after the procedure.
  • Participation involves no extra visits or tests beyond usual care.
  • Your medical team will decide by chance when you receive the heparin.
  • Results could help make heart procedures safer for many people.

Who may be eligible?

To be part of this study, you need to be at least 18 years old, male or female, and planning to have a heart procedure (PCI) through your wrist. You also need to have health insurance and be able to understand the study details and give your permission to take part.

There are some reasons why you wouldn't be able to join. For example, if you've ever had a serious reaction to heparin (the blood-thinning medicine), or if you've recently had significant bleeding within the last six months. Also, if you're already taking other specific types of blood-thinning medication, or if you are pregnant or breastfeeding, this study would not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Are you having a heart procedure (PCI) through your wrist?
  3. Do you currently have health insurance?
  4. Have you NOT had any serious bleeding in the last 6 months?
  5. Are you NOT pregnant or breastfeeding?
  6. Are you NOT taking 'anti-vitamin K' or 'direct oral anticoagulants' (DOACs) for blood thinning?
Answer every question to see your result.

What does participation involve?

If you join this study, your heart procedure will be carried out as planned. The only difference is that the timing of your heparin blood-thinning medicine will be decided by chance, either before or after the small tube (sheath) is placed in your wrist. This is the main part of the study intervention. You won't need extra visits beyond your usual medical care, but research staff will collect information during your hospital stay and at a follow-up appointment within 48 hours of your procedure, and then again after 30 days. The total duration of your participation in the study follow-up will be about 30 days.

Potential risks and benefits

Participating in this study might help us learn how to make heart procedures through the wrist even safer for future patients. While there's no direct personal benefit guaranteed, you will receive standard medical care for your heart condition. There are always risks with any medical procedure, and the risks related to the heparin medication (like increased bleeding) are generally well-known and carefully managed by your doctors. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

  • Hôpitaux Universitaires de Strasbourg
    Verified postcode
    Strasbourg, France· Recruiting

Common questions

What is 'radial access PCI'?

It's a common heart procedure where doctors access your heart's blood vessels through a small entry point in your wrist artery.

Why is the timing of heparin important?

Heparin helps thin your blood to prevent clots. We want to find out if giving it earlier helps prevent the wrist artery from getting blocked after the procedure.

Will I know if I get heparin before or after?

The timing is decided by chance, like flipping a coin, so neither you nor your doctor will choose. This helps us get a fair comparison.

Are there any extra tests for this study?

No, there are no extra tests beyond what you would normally have for your heart procedure and follow-up care.

What if I change my mind about participating?

You can decide to stop participating at any point without it affecting your medical care or relationship with your healthcare team.

How to find out more

Pr Patrick OHLMANN Pr Patrick OHLMANN, Professor

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Timing of Anticoagulant Administration During Radial Access …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

Community discussion

Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.