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HD PCI

Official Title

A Randomized Trial of High vs. Low Dose Heparin for PCI

Status

Ongoing

Overview

The objectives of HD PCI are to determine if higher-dose heparin in patients undergoing percutaneous coronary intervention (PCI) for non-ST elevation acute coronary syndrome (NSTEACS) or stable angina reduces the composite of death, myocardial infarction (MI) or target vessel revascularization (TVR) compared to lower dose heparin in patients undergoing PCI for NSTEACS or stable angina; to determine if lower dose heparin reduces serious bleeding, as measured by the need for blood transfusion after PCI; and to determine if higher dose heparin improves the net benefit outcome of death, MI, TVR or need for blood transfusion.

Study Design

Randomized registry-based trial with cluster crossover design

Primary Endpoint

Primary Efficacy: Death, MI or TVR up to 30 days of PCI
Primary Safety: Blood Transfusion within 30 days of PCI
Key Net Benefit: Death, MI, TVR or blood transfusion within 30 days of PCI

Number of Patients

15366

Number of Sites

22

Number of Countries

2

Study Period

2019-2021

Principal Investigator

Sanjit Jolly

Program Manager

Brandi Meeks

Research Coordinator

Tara Pinto