Higher vs. Lower Dose Heparin for PCI (HD-PCI)

Population Health Research Institute (PHRI)

Status: Enrolling

Conditions: Percutaneous Coronary Intervention; Cardiovascular Diseases

Treatments: Drug: Higher Dose UFH; Drug: Lower Dose UFH

Study type: Interventional

Funder types: Other

Identifiers

NCT04049591

HD PCI

Details and patient eligibility

About

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).

Full 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).

Enrollment: 16,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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16,000 participants in 2 patient groups

Higher Dose Unfractionated Heparin Treatment Period

Active Comparator group

Description:

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.

Treatment:

Drug: Higher Dose UFH

Lower Dose Unfractionated Heparin Treatment Period

Active Comparator group

Description:

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.

Treatment:

Drug: Lower Dose UFH