Menu
Recruiting NCT04049591

Higher vs. Lower Dose Heparin for PCI

No phase Interventional Cardiovascular Diseases Percutaneous Coronary Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Higher Dose UFH, Lower Dose UFH.
Who it may be relevant to
Registry conditions: Cardiovascular Diseases, Percutaneous Coronary Intervention. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Drug Higher Dose UFH
    Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
  • Drug Lower Dose UFH
    Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures

Primary outcome measures

  • Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization [Time frame: up to 30 days after PCI]
Secondary outcome measures (2)
  • Number of Participants with major bleeding [Time frame: up to 30 days after PCI]
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Prevention

Study locations

Canada · 1 center
  • Hamilton Health Sciences, General Hospital — Hamilton

Publications

  • 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. 2026 Apr;294:107330. doi: 10.1016/j.ahj.2025.107330. Epub 2 PMID 41443541

Identifiers

NCT: NCT04049591 · HD PCI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗