Higher vs. Lower Dose Heparin for PCI (HD-PCI)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Percutaneous Coronary Intervention
• Intervention / Treatment: Drug: Higher Dose UFH; Drug: Lower Dose UFH

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).

• Study Type: Interventional
• Enrollment (Estimated): 16000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Skuriat; Phone Number: 905-521-2100; Email: HD-PCI@phri.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Recruiting
      • Hamilton Health Sciences, General Hospital
      • Contact: Sanjit Jolly, MD; Email: HD-PCI@phri.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Higher Dose Unfractionated Heparin Treatment Period; 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; Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
Active Comparator: Lower Dose Unfractionated Heparin Treatment Period; 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; Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Population Health Research Institute
• Investigators: Principal Investigator: Sanjit Jolly, MD, Population Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2022
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): August 1, 2025

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 6, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: HD PCI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No