Cardiovascular Diseases, Percutaneous Coronary Intervention
Conditions
Brief summary
HD PCI is a multicenter, randomized, registry-based, cluster crossover design trial of higher dose versus lower dose heparin in patients undergoing elective percutaneous coronary intervention (PCI).
Detailed description
The primary objective of HD PCI is to compare the effect of a policy of higher dose heparin (100 U/kg) use to a policy of lower dose heparin (70 U/kg) use on death, myocardial infarction (MI) or target vessel revascularization (TVR) in patients undergoing elective percutaneous coronary intervention (PCI).
Interventions
DRUGHigher Dose UFH
Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
DRUGLower Dose UFH
Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Cluster crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization | up to 30 days after PCI |
Secondary
| Measure | Time frame |
|---|---|
| Number of Participants with major bleeding | up to 30 days after PCI |
| Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding | up to 30 days after PCI |
Other
| Measure | Time frame |
|---|---|
| Number of Participants with either of the following: death or myocardial infarction | up to 30 days after PCI |
| Number of Participants with definite stent thrombosis | up to 30 days after PCI |
Countries
Canada
Contacts
Primary ContactJessica Tyrwhitt
Outcome results
None listed