Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Comparing higher and lower doses of heparin for heart procedures

Official title: A Randomized Trial of Higher vs. Lower Dose Heparin for PCI

Run by Population Health Research Institute · NCT04049591 · Data updated 2026-11-12

This study is testing whether using a higher dose of heparin during heart procedures helps patients do better than using a lower dose.

More Cardiovascular Diseases trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment16000 (estimated)
SponsorPopulation Health Research Institute
Academic / other
Locations1 site (Hamilton, Ontario)
StatusRecruiting
StartedMarch 2, 2022
Main results expectedOctober 8, 2024
Study endsDecember 2025
Registry record updatedJuly 31, 2025
Trial IDNCT04049591 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are patients scheduled for elective percutaneous coronary intervention.

Probably not a fit

Patients under 18 years old or those requiring chronic total occlusion PCI may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial investigates the effects of higher dose heparin (100 U/kg) versus lower dose heparin (70 U/kg) in patients undergoing elective percutaneous coronary intervention (PCI). It employs a multicenter, randomized, registry-based, cluster crossover design to assess outcomes such as death, myocardial infarction, and target vessel revascularization. The study aims to determine which dosing strategy is more effective in improving patient outcomes during PCI procedures.

Why it matters

Potential benefit: If successful, this study could lead to improved safety and effectiveness of heparin use during heart procedures.

How similar studies have gone: Other studies have explored heparin dosing in PCI, but this specific comparison of higher versus lower doses in a registry-based design is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

\- Patients undergoing elective PCI

Exclusion Criteria:

* Age \<18 years
* Planned chronic total occlusion PCI
* Non-resident precluding follow up through local registries

Hospital (Cluster) Eligibility Criteria

Hospitals will be eligible to participate if they meet the following criteria:

* Submit PCI procedure data to a compatible registry that is able to provide data for the trial
* Site agrees to manage patients as per the higher or lower dose heparin policy in place during the given crossover period

Where it's running

  • Hamilton Health Sciences, General Hospital
    Hamilton, Ontario, Canada
    Recruiting

Study contacts

  • Principal investigator: Sanjit Jolly, MD — Population Health Research Institute
  • Study coordinator: Jessica Tyrwhitt
  • Email: HD-PCI@phri.ca
  • Phone: 905-521-2100

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.