Higher vs. Lower Dose Heparin for PCI

Not Applicable

Recruiting

• Conditions: Cardiovascular Diseases; Percutaneous Coronary Intervention
• Interventions: Drug: Higher Dose UFH; Drug: Lower Dose UFH

• Registration Number: NCT04049591
• Lead Sponsor: Population Health Research Institute

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).

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-06
• Study First Posted: 2019-08-08
• Study Start: 2022-03-02
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-17
• Last Update Posted: 2024-06-20
• Primary Completion: 2024-10
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 16000

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Higher Dose Unfractionated Heparin Treatment Period	Higher Dose UFH	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	Lower Dose UFH	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization	up to 30 days after PCI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hamilton Health Sciences, General Hospital; 🇨🇦 Hamilton, Ontario, Canada