Cardiovascular DiseasesHD-PCINCT04049591
Higher vs. Lower Dose Heparin for PCI
A study testing Higher Dose UFH and Lower Dose UFH in people with Cardiovascular Diseases and Percutaneous Coronary Intervention, run by Population Health Research Institute at 1 site in Canada.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Percutaneous Coronary Intervention
- What is being tested?
- Higher Dose UFH and Lower Dose UFH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,000 participants
- Where
- 1 siteCanada
- Study dates
- 2 Mar 2022to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing elective PCI
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Hamilton Health Sciences, General Hospital
Hamilton, Ontario, L8L 2X2
Sanjit Jolly, MD, HD-PCI@phri.ca
About this study
Official title: A Randomized Trial of Higher vs. Lower Dose Heparin for PCI
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).
Read the detailed 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).
- Being tested
- Higher Dose UFH, Lower Dose UFH
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Higher Dose UFHDrug
Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
Lower Dose UFHDrug
Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures
| Study group | Role | What they receive |
|---|---|---|
| Higher Dose Unfractionated Heparin Treatment Period | Active comparator | 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. Receives: Drug: Higher Dose UFH |
| Lower Dose Unfractionated Heparin Treatment Period | Active comparator | 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. Receives: Drug: Lower Dose UFH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization
Measured: up to 30 days after PCI
Secondary outcomes (2)
Number of Participants with major bleeding
Measured: up to 30 days after PCI
Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding
Measured: up to 30 days after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2019
- Study start2 Mar 2022
- Primary completion8 Oct 2024
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster crossover
- Masking
- None (open label)
- Enrolment
- 16,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sanjit Jolly, MD, Principal investigator, Population Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04049591
- Sponsor's protocol ID
- HD PCI
- Acronym
- HD-PCI
- Status last verified
- Jul 2025
- First submitted
- 6 Aug 2019
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
d'Entremont MA, Lee SF, Wijeysundera HC, Tsang MB, Amlani S, Wassef A, Lavi S, So DYF, Betz J, Tyrwhitt J, Graham J, Cantor WJ, Bagherli A, Vijayaraghavan R, Jolly SS. Design and rationale of the HD PCI trial: A cluster randomized crossover trial of higher vs. lower dose heparin for elective percutaneous coronary intervention. Am Heart J. 2026 Apr;294:107330. doi: 10.1016/j.ahj.2025.107330. Epub 2025 Dec 22.
PubMed 41443541
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Higher vs. Lower Dose Heparin for PCI
- ClinicalTrials.gov ID
- NCT04049591
- Acronym / sponsor ID
- HD-PCI / HD PCI
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16,000 participants (estimated)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster crossover
| Arm | Type | Receives |
|---|---|---|
| Higher Dose Unfractionated Heparin Treatment Period | Active comparator | Drug: Higher Dose UFHA 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. |
| Lower Dose Unfractionated Heparin Treatment Period | Active comparator | Drug: Lower Dose UFHA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective PCI
Key exclusion criteria (7 listed)
- Age <18 years
- Planned chronic total occlusion PCI
- Non-resident precluding follow up through local registries
- Hospital (Cluster) Eligibility Criteria
- Submit PCI procedure data to a compatible registry that is able to provide data for the trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Higher Dose UFHCentre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures | Drug | Higher Dose Unfractionated Heparin Treatment Period |
| Lower Dose UFHCentre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures | Drug | Lower Dose Unfractionated Heparin Treatment Period |
Primary outcome
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization
Time frame: up to 30 days after PCI
2 secondary outcomes
Number of Participants with major bleeding
Time frame: up to 30 days after PCI
Number of Participants with any of the following: death, myocardial infarction, target vessel revascularization or major bleeding
Time frame: up to 30 days after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Derived from this study: PubMed 41443541d'Entremont MA, Lee SF, Wijeysundera HC, Tsang MB, Amlani S, Wassef A, Lavi S, So DYF, Betz J, Tyrwhitt J, Graham J, Cantor WJ, Bagherli A, Vijayaraghavan R, Jolly SS. Design and rationale of the HD PCI trial: A cluster randomized crossover trial of higher vs. lower dose heparin for elective percutaneous coronary intervention. Am Heart J. 2026 Apr;294:107330. doi: 10.1016/j.ahj.2025.107330. Epub 2025 Dec 22.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiovascular Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sanjit Jolly, MD principal investigator
Population Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Higher Dose UFH and Lower Dose UFH in people with Cardiovascular Diseases and Percutaneous Coronary Intervention, run by Population Health Research Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Tyrwhitt (905-521-2100, HD-PCI@phri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with any of the following: death, myocardial infarction or target vessel revascularization (time frame: up to 30 days after PCI). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04049591, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.