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Anticoagulant

Heparin Dosing for Percutaneous Coronary Intervention (HD-PCI Trial)

N/A

Recruiting

Research Sponsored by Population Health Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing elective PCI

- Patients undergoing elective PCI

Must not have

Planned chronic total occlusion PCI

Age <18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 20 Other Conditions

No Placebo-Only Group

Summary

This trial is testing whether higher or lower doses of heparin are better for people undergoing a specific kind of heart procedure.

Who is the study for?

This trial is for adults who need an elective procedure to open blocked arteries in the heart (PCI). Hospitals must submit data to a registry and follow the heparin dose policy. It's not for those under 18, planning a specific complex PCI, or non-residents who can't be followed up locally.

What is being tested?

The HD PCI trial compares two dosing strategies of heparin: a higher dose versus a lower dose during heart artery-opening procedures. Patients are randomly assigned to either group across different hospitals that switch policies periodically.

What are the potential side effects?

Heparin can cause bleeding, bruising at injection sites, allergic reactions, and in rare cases may lead to an unusual clotting disorder called HITT (heparin-induced thrombocytopenia and thrombosis).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a planned procedure to open blocked arteries in my heart.

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I am scheduled for a planned procedure to open blocked arteries in my heart.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am scheduled for a procedure to open a completely blocked heart artery.

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 20 Other Conditions

This treatment demonstrated efficacy for 20 other conditions.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Higher Dose Unfractionated Heparin Treatment PeriodActive Control1 Intervention

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 II: Lower Dose Unfractionated Heparin Treatment PeriodActive Control1 Intervention

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.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Population Health Research InstituteLead Sponsor

164 Previous Clinical Trials

702,514 Total Patients Enrolled

Sanjit Jolly, MDStudy ChairPopulation Health Research Institute

Media Library

Higher Dose UFH (Anticoagulant) Clinical Trial Eligibility Overview. Trial Name: NCT04049591 — N/A

$Cardiovascular Disease Research Study Groups: Higher Dose Unfractionated Heparin Treatment Period, Lower Dose Unfractionated Heparin Treatment Period$