Higher vs. Lower Dose Heparin for PCI
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Age <18 years
Planned chronic total occlusion PCI
Non-resident precluding follow up through local registries
Submit PCI procedure data to a compatible registry that is able to provide data for the trial
Trial design
Design model
Crossover
Treatments tested in this trial
Higher Dose UFH
DrugCentre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
Lower Dose UFH
DrugCentre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures
Treatment groups
16,000 Participants
are divided into 2 treatment groupsGroup A: Higher Dose Unfractionated Heparin Treatment PeriodActive comparator 1 intervention
Group B: Lower Dose Unfractionated Heparin Treatment PeriodActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization
Time frame
up to 30 days after PCISecondary outcomes
1
Number of Participants with major bleeding
Time frame
up to 30 days after PCI2
Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding
Time frame
up to 30 days after PCIOther outcomes
1
Number of Participants with either of the following: death or myocardial infarction
Time frame
up to 30 days after PCI2
Number of Participants with definite stent thrombosis
Time frame
up to 30 days after PCISponsors and contacts
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Source ClinicalTrials.gov