Comparing higher and lower doses of heparin for heart procedures
A Randomized Trial of Higher vs. Lower Dose Heparin for PCI
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Population Health Research Institute Academic / other |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT04049591 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for elective percutaneous coronary intervention.
Not a fit: Patients under 18 years old or those requiring chronic total occlusion PCI may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hamilton, Ontario
- 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
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.