Comparing Higher Dose UFH with Lower Dose UFH for cardiovascular diseases
Official title: Higher vs. Lower Dose Heparin for PCI
A Randomized Trial of Higher vs. Lower Dose Heparin for PCI
- 2 groups
- One site, in Hamilton
- Recruiting
Interventions
- Medication
Higher Dose UFH
Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
- Medication
Lower Dose UFH
Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Hamilton Health Sciences, General Hospital
Hamilton, Ontario
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +\- Patients undergoing elective PCI
Exclusion
- −Age \<18 years
- −Planned chronic total occlusion PCI
- −Non-resident precluding follow upFollow-upContinued check-ins after the treatment part is finished.Read more → through local registries
- −Hospital (Cluster) Eligibility CriteriaEligibility criteriaThe full list of requirements for taking part in a study.Read more →
- −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
- −SiteTrial siteA hospital or clinic where a study is actually run.Read more → agrees to manage patients as per the higher or lower dose heparin policy in place during the given crossoverCrossoverEach participant receives both treatments in turn, in a set order.Read more → period
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a way to prevent a condition from developing.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Higher Dose UFH.
Registry label: A: Higher Dose Unfractionated Heparin Treatment Period
Group B, the comparison group, receives Lower Dose UFH.
Registry label: B: Lower Dose Unfractionated Heparin Treatment Period
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 16,000 people.
The study is currently expected to finish around December 2025.
The main measurement is taken over: up to 30 days after PCI.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization — measured over up to 30 days after PCI.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04049591 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Higher Dose UFHDrug
Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Lower Dose UFHDrug
Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: up to 30 days after PCI.
The study as a whole is currently expected to finish around 2025-12.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 16,000 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Hamilton, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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).
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.