Higher vs. Lower Dose Heparin for PCI

Study Overview
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Brief Summary
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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).

Detailed Description
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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).

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

Conditions
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Cardiovascular Diseases, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Higher Dose UFH
* Drug: Lower Dose UFH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Cluster crossover
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Higher Dose Unfractionated Heparin Treatment Period<br>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. | Drug: Higher Dose UFH<br>* Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures<br>|
| Active Comparator: Lower Dose Unfractionated Heparin Treatment Period<br>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. | Drug: Lower Dose UFH<br>* Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |