Recruiting

Heparin vs. HeparinHigher vs. Lower Dose Heparin for PCI

Sponsor:

Population Health Research Institute

Code:

NCT04049591

Conditions

Cardiovascular Diseases

Percutaneous Coronary Intervention

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Higher Dose UFH

Lower Dose UFH

Study Details

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).

Conditions

Cardiovascular Diseases

Percutaneous Coronary Intervention

Study ID

NCT04049591

Start date

Mar 2, 2022

Status verified date

Jul, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Oct 8, 2024

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

16000 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Jessica Tyrwhitt

905-521-2100 HD-PCI@phri.ca

Locations

Hamilton Health Sciences, General Hospital

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Sanjit Jolly, MD

HD-PCI@phri.ca

More Information

Sponsor

Population Health Research Institute

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Population Health Research Institute on 2025-07-31.