Higher vs. Lower Dose Heparin for PCI

NCT ID: NCT04049591

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-02

Study Completion Date

2025-12-31

Brief Summary

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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

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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).

Conditions

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Cardiovascular Diseases Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cluster crossover
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Higher Dose UFH

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Lower Dose UFH

Intervention Type DRUG

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

Interventions

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Higher Dose UFH

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

Intervention Type DRUG

Lower Dose UFH

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Population Health Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sanjit Jolly, MD

Role: PRINCIPAL_INVESTIGATOR

Population Health Research Institute

Locations

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Hamilton Health Sciences, General Hospital

Hamilton, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Jessica Tyrwhitt

Role: CONTACT

905-521-2100

Facility Contacts

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Sanjit Jolly, MD

Role: primary

Other Identifiers

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HD PCI

Identifier Type: -

Identifier Source: org_study_id

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