NCT04049591

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16,000

participants targeted

Target at P75+ for not_applicable cardiovascular-diseases

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable cardiovascular-diseases

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2019

Completed
2.6 years until next milestone

Study Start

First participant enrolled

March 2, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 8, 2024

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

July 31, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

August 6, 2019

Last Update Submit

July 28, 2025

Conditions

Cardiovascular DiseasesPercutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (1)

  • Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization

    up to 30 days after PCI

Secondary Outcomes (2)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Higher Dose Unfractionated Heparin Treatment Period

ACTIVE COMPARATOR

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

Lower Dose Unfractionated Heparin Treatment Period

ACTIVE COMPARATOR

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

Interventions

Higher Dose UFHDRUG

Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures

Higher Dose Unfractionated Heparin Treatment Period
Lower Dose UFHDRUG

Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures

Lower Dose Unfractionated Heparin Treatment Period

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Patients undergoing elective PCI

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton Health Sciences, General Hospital

Hamilton, Ontario, L8L 2X2, Canada

RECRUITING

Related Publications (1)

  • d'Entremont MA, Lee SF, Wijeysundera HC, Tsang MB, Amlani S, Wassef A, Lavi S, So DYF, Betz J, Tyrwhitt J, Graham J, Cantor WJ, Bagherli A, Vijayaraghavan R, Jolly SS. Design and rationale of the HD PCI trial: A cluster randomized crossover trial of higher vs. lower dose heparin for elective percutaneous coronary intervention. Am Heart J. 2025 Dec 22;294:107330. doi: 10.1016/j.ahj.2025.107330. Online ahead of print.

    PMID: 41443541DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Sanjit Jolly, MD

    Population Health Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Tyrwhitt

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Cluster crossover
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2019

First Posted

August 8, 2019

Study Start

March 2, 2022

Primary Completion

October 8, 2024

Study Completion

December 1, 2025

Last Updated

July 31, 2025

Record last verified: 2025-07

Locations

CA(1)