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NCT04049591 Clinical Trial

Higher vs. Lower Dose Heparin for PCI

Cardiovascular Diseases Clinical Trial

— HD-PCI  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04049591
Other study ID # HD PCI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 2, 2022
Est. completion date August 2025

Study information
Verified date June 2024
Source Population Health Research Institute
Contact Jessica Tyrwhitt
Phone 905-521-2100
Email HD-PCI@phri.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 16000
Est. completion date August 2025
Est. primary completion date October 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Higher Dose UFH
Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
• Lower Dose UFH
Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures

Locations
Country Name City State
Canada Hamilton Health Sciences, General Hospital Hamilton Ontario

Sponsors (1)
Lead Sponsor Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Other Number of Participants with either of the following: death or myocardial infarction up to 30 days after PCI
Other Number of Participants with definite stent thrombosis up to 30 days after PCI
Primary Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization up to 30 days after PCI
Secondary Number of Participants with major bleeding up to 30 days after PCI
Secondary Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding up to 30 days after PCI
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