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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher Dose Unfractionated Heparin Treatment Period | Active Comparator | A centre wide policy of administering 100 U/kg bolus of intravenous unfractionated heparin (UFH) for elective percutaneous coronary intervention (PCI) procedures will be implemented during the Higher Dose UFH treatment period. |
|
| Lower Dose Unfractionated Heparin Treatment Period | Active Comparator | A centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures will be implemented during the Lower Dose UFH treatment period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher Dose UFH | Drug | Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization | up to 30 days after PCI |
| Measure | Description | 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 |
| Measure | Description | 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 |
Inclusion Criteria:
- Patients undergoing elective PCI
Exclusion Criteria:
Hospital (Cluster) Eligibility Criteria
Hospitals will be eligible to participate if they meet the following criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jessica Tyrwhitt | Contact | 905-521-2100 | HD-PCI@phri.ca |
| Name | Affiliation | Role |
|---|---|---|
| Sanjit Jolly, MD | Population Health Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton Health Sciences, General Hospital | Recruiting | Hamilton | Ontario | L8L 2X2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41443541 | Derived | d'Entremont MA, Lee SF, Wijeysundera HC, Tsang MB, Amlani S, Wassef A, Lavi S, So DYF, Betz J, Tyrwhitt J, Graham J, Cantor WJ, Bagherli A, Vijayaraghavan R, Jolly SS. Design and rationale of the HD PCI trial: A cluster randomized crossover trial of higher vs. lower dose heparin for elective percutaneous coronary intervention. Am Heart J. 2026 Apr;294:107330. doi: 10.1016/j.ahj.2025.107330. Epub 2025 Dec 22. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Cluster crossover
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| Lower Dose UFH | Drug | Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures |
|