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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 16000 (estimated) |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Status | Recruiting |
| Started | March 2, 2022 |
| Main results expected | October 8, 2024 |
| Study ends | December 2025 |
| Registry record updated | July 31, 2025 |
| Trial ID | NCT04049591 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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.