Cardiac DiseasePhase 3NCT04374799
Heparin vs Placebo for Cardiac Catheterization
A Phase 3 study testing Heparin in people with Cardiac Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites in Canada.
Trial summary
Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- Heparin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,623 participants
- Where
- 2 sitesCanada
- Study dates
- 5 Oct 2020to Dec 2026
- Phase
- Phase 3
- 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
- diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation
Who cannot join
- abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Hamilton Health Sciences
Hamilton, Ontario
Shamir Mehta
Shamir Mehta, MD
- Recruiting
London Health Sciences Centre
London, Ontario, N6A5A5
Shahar Lavi, MD, 519-663-3611, shahar.lavi@lhsc.on.ca
Cassandra Wagner, MSc, 519-685-8500 ext. 35625, cassandra.wagner@lhsc.on.ca
About this study
Official title: A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.
Read the detailed description
Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.
- Conditions
- Cardiac Disease
- Being tested
- Heparin, Placebos
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HeparinDrug
two doses of heparin
PlacebosDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Low dose heparin | Active comparator | heparin (25 IU/Kg -maximal dose 3,000 IU) Receives: Drug: Heparin |
| High dose heparin | Active comparator | heparin 50 IU/kg -maximal dose 5,000 IU Receives: Drug: Heparin |
| Placebo | Placebo comparator | Normal saline 0.9%. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
radial artery occlusion
by ultrasound
Measured: 1 hour
Secondary outcomes (6)
Hematoma> 5 cm
Hematoma at access site
Measured: one hour post procedure
access site bleeding
any bleeding
Measured: 1 hour
non access site bleeding
bleeding not related to access site, such as gastrointestinal
Measured: 1 day
access site complications
pseudoaneurysm, arteriovenous fistula
Measured: 1 day
wrist band duration
How long wrist band was on
Measured: 3 hours
time to discharge
when patient was able to leave the post procedure care area
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2020
- Study start5 Oct 2020
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (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 Cardiac DiseaseStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,623 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04374799
- Sponsor's protocol ID
- 2102
- Status last verified
- Aug 2025
- First submitted
- 30 Apr 2020
- Last updated
- 20 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lavi S, Shadpour S, Allen E, Ogunsakin RE, Mehta SR. Design and rational of the the PRACTICAL-HERO trial: A randomized trial of higher and lower doses of heparin vs placebo for elective diagnostic coronary angiography. Am Heart J. 2026 Aug;298:107441. doi: 10.1016/j.ahj.2026.107441. Epub 2026 Apr 13.
PubMed 41985829
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
- ClinicalTrials.gov ID
- NCT04374799
- Acronym / sponsor ID
- 2102
- Conditions
- Cardiac Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,623 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 5 Oct 2020 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 May 2020 (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.
Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.
Detailed description
Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose heparin | Active comparator | Drug: Heparinheparin (25 IU/Kg -maximal dose 3,000 IU) |
| High dose heparin | Active comparator | Drug: Heparinheparin 50 IU/kg -maximal dose 5,000 IU |
| Placebo | Placebo comparator | Drug: PlacebosNormal saline 0.9%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation
Key exclusion criteria (1 listed)
- abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation
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 |
|---|---|---|
| Heparintwo doses of heparin | Drug | High dose heparin, Low dose heparin |
| Placebosplacebo | Drug | Placebo |
Primary outcome
radial artery occlusion
Time frame: 1 hour
by ultrasound
6 secondary outcomes
Hematoma> 5 cm
Time frame: one hour post procedure
access site bleeding
Time frame: 1 hour
non access site bleeding
Time frame: 1 day
access site complications
Time frame: 1 day
wrist band duration
Time frame: 3 hours
time to discharge
Time frame: 1 day
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 20 Feb 2026.
- Derived from this study: PubMed 41985829Lavi S, Shadpour S, Allen E, Ogunsakin RE, Mehta SR. Design and rational of the the PRACTICAL-HERO trial: A randomized trial of higher and lower doses of heparin vs placebo for elective diagnostic coronary angiography. Am Heart J. 2026 Aug;298:107441. doi: 10.1016/j.ahj.2026.107441. Epub 2026 Apr 13.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Heparin in people with Cardiac Disease, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 2 sites 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 1 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 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Shahar Lavi, MD (519-6633611, Shahar.lavi@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radial artery occlusion (time frame: 1 hour). 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 NCT04374799, 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 20 Feb 2026.