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NCT Number: NCT04049591

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).

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Key information

Conditions

Cardiovascular Diseases Percutaneous Coronary Intervention

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hamilton Health Sciences, General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location status: Recruiting

Location contact

Sanjit Jolly, MD

CONTACT

[email protected]

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Higher Dose UFH

Drug

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

Lower Dose UFH

Drug

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

Primary outcomes

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

    Time frame: up to 30 days after PCI

Secondary outcomes

  1. Number of Participants with major bleeding

    Time frame: up to 30 days after PCI

  2. Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding

    Time frame: up to 30 days after PCI

Other outcomes

  1. Number of Participants with either of the following: death or myocardial infarction

    Time frame: up to 30 days after PCI

  2. Number of Participants with definite stent thrombosis

    Time frame: up to 30 days after PCI

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica Tyrwhitt

CONTACT

[email protected]

905-521-2100

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: HD-PCI

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Aug 8, 2019
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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