Heparin Dosing for Percutaneous Coronary Intervention

(HD-PCI Trial)

Overseen By Jessica Tyrwhitt

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Population Health Research Institute

Disqualifiers: Age <18, Chronic occlusion PCI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Duration not specified

16000 Participants Needed

Trial Summary

What is the purpose of 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).

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the idea that Heparin Dosing for Percutaneous Coronary Intervention is an effective drug?

The available research shows that unfractionated heparin (UFH) is commonly used during percutaneous coronary intervention (PCI) for various heart conditions. For example, one study focused on using UFH in patients with ST-segment elevation myocardial infarction (STEMI), a type of heart attack, before PCI. Another study compared different dosing strategies of UFH during elective PCI, suggesting its effectiveness in this procedure. Although the studies explore different aspects of UFH use, they collectively support its role in PCI, indicating that it is a widely used and effective drug for this purpose. ^{1 2 3 4 5}

What safety data is available for heparin dosing in PCI?

Safety data for heparin dosing in percutaneous coronary intervention (PCI) includes studies comparing different dosing strategies of unfractionated heparin (UFH), such as fixed dose versus weight-adjusted dosing, and low-dose intracoronary UFH. Additionally, comparisons between UFH and enoxaparin for PCI in ST-segment elevation myocardial infarction (STEMI) patients have been conducted. These studies assess the safety and efficacy of various UFH dosing protocols. ^{1 3 4 6 7}

Is the drug Higher Dose UFH, Lower Dose UFH a promising treatment for Percutaneous Coronary Intervention?

Yes, the drug Higher Dose UFH, Lower Dose UFH, also known as Unfractionated Heparin, is promising for Percutaneous Coronary Intervention. It is frequently used and studied for its effectiveness and safety in heart procedures, helping to prevent blood clots during these interventions. ^{1 2 3 8 9}

Research Team

Sanjit Jolly, MD

Principal Investigator

Population Health Research Institute

Eligibility Criteria

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.

Inclusion Criteria

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

Hospitals will be eligible to participate if they meet the following criteria:

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

Exclusion Criteria

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

Non-resident precluding follow up through local registries

I am under 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a higher dose (100 U/kg) or lower dose (70 U/kg) of unfractionated heparin during elective PCI procedures

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on outcomes like death, myocardial infarction, or target vessel revascularization

4-8 weeks

Treatment Details

Interventions

• Higher Dose UFH
• Lower Dose UFH

Trial Overview 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.

Participant Groups

Group I: Higher Dose Unfractionated Heparin Treatment Period Active Control 1 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 Period Active Control 1 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.

Higher Dose UFH is already approved in European Union, United States, Canada, China for the following indications:

Approved in European Union as Unfractionated Heparin for:

• Prevention of thromboembolic disorders
• Treatment of deep vein thrombosis
• Treatment of pulmonary embolism
• Prevention of clotting in extracorporeal circuits during cardiopulmonary bypass surgery

Approved in United States as Unfractionated Heparin for:

• Prevention and treatment of deep vein thrombosis and pulmonary embolism
• Prevention of postoperative deep vein thrombosis and pulmonary embolism in patients undergoing major abdominothoracic surgery
• Prevention of clotting in arterial and cardiac surgery

Approved in Canada as Unfractionated Heparin for:

• Thromboembolic disorders
• Deep vein thrombosis
• Pulmonary embolism
• Cardiopulmonary bypass surgery

Approved in China as Unfractionated Heparin for:

• Prevention and treatment of thromboembolic disorders
• Deep vein thrombosis
• Pulmonary embolism
• Cardiopulmonary bypass surgery

Who Is Running the Clinical Trial?

Population Health Research Institute

Lead Sponsor

Trials

165

Recruited

717,000+

Findings from Research

In a study of 698 patients undergoing elective percutaneous coronary intervention (PCI), a fixed dose of 3000 U of unfractionated heparin (UFH) showed similar effectiveness in preventing troponin I release compared to a weight-adjusted dose of 70 U/kg, indicating that lower dosing may be sufficient.

Both dosing strategies resulted in no major complications, such as deaths or significant bleeding, suggesting that a fixed dose of heparin is safe for use during PCI in patients with stable angina.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unfractionated heparin during elective PCI: fixed dose or weight adjusted? Kidambi, A., Mayurathan, G., Viswanathan, G., et al.[2015]

In a study of 41,631 patients with STEMI, pretreatment with unfractionated heparin (UFH) before PCI significantly reduced coronary artery occlusion, with a number needed to treat (NNT) of 12, indicating it is effective in improving coronary outcomes.

UFH pretreatment also showed a potential reduction in 30-day mortality (NNT of 94), but this finding was not consistent across all analyses, suggesting further investigation is needed to confirm its impact on mortality without increasing the risk of major bleeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pretreatment with heparin in patients with ST-segment elevation myocardial infarction: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Emilsson, OL., Bergman, S., Mohammad, MA., et al.[2023]

In a study of 66 hemodialysis patients, switching from a standard-dose to a low-dose unfractionated heparin (UFH) protocol significantly reduced the average UFH dose while maintaining dialysis adequacy, indicating that lower doses can be effective and safe.

The low-dose UFH protocol allowed for a reduction in the weekly dose of erythropoiesis-stimulating agents (ESA) without negatively impacting hemoglobin levels, suggesting potential benefits in anemia management for patients undergoing hemodialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of low-dose heparin in hemodialysis. Murea, M., Russell, GB., Daeihagh, P., et al.[2022]

In a study of 200 patients undergoing elective percutaneous coronary intervention (PCI), low-dose intracoronary unfractionated heparin (UFH) was found to be as safe and effective as standard intravenous UFH, with similar rates of major complications like death and myocardial infarction at both 30 days and 6 months.

The use of low-dose intracoronary UFH resulted in lower healthcare costs at 30 days compared to the control group, suggesting a more economical approach to anticoagulation during PCI without compromising patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The REDUCED (a RandomisED stUdy Comparing standard systemic anticoagulation thErapy to low Dose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention. Ari, H., Kivaç, E., Ari, S., et al.[2019]

This study will evaluate the safety of two different doses of unfractionated heparin (UFH) during percutaneous coronary intervention (PCI) in about 4,000 high-risk patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) who were initially treated with fondaparinux.

The primary focus is on comparing a standard ACT-guided UFH regimen to a lower weight-adjusted UFH dose, with the goal of determining which regimen results in fewer major bleeding complications and better overall clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. Steg, PG., Mehta, S., Jolly, S., et al.[2018]

In a study of 580 patients undergoing percutaneous coronary intervention (PCI) for STEMI, enoxaparin was found to be more effective than unfractionated heparin (UFH) in reducing the risk of death and recurrent myocardial infarction, both during hospitalization and up to 30 days post-procedure.

Patients receiving enoxaparin were more likely to achieve therapeutic anticoagulation during the procedure without an increase in major bleeding events, suggesting it is a safer and more effective option for anticoagulation in STEMI patients undergoing PCI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heparin or enoxaparin anticoagulation for primary percutaneous coronary intervention. Brieger, D., Collet, JP., Silvain, J., et al.[2022]

A study comparing two heparin dosing protocols found that both fully weight-based and non-weight-based titration methods were similarly effective in achieving therapeutic activated partial thromboplastin time (aPTT), with a high success rate of around 96% in both groups.

However, patients on the non-weight-based protocol had a lower initial success rate in achieving therapeutic aPTT when treated under low-target protocols, indicating that while both methods are effective overall, the fully weight-based approach may be more reliable for certain patient groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of a Fully Weight-Based Protocol with a Non-Weight-Based Dosage Titration Protocol for IV Unfractionated Heparin: A Before-and-After Study. Cameron, T., Chua, D., Shalansky, S., et al.[2023]

In a study of 123 STEMI patients treated with tenecteplase and intravenous UFH, low-dose Enoxaparin (4,000 U once daily) showed comparable safety and efficacy to full-dose Enoxaparin (100 U/kg twice daily) in preventing complications like hemorrhages and reinfarction.

Both dosing regimens resulted in similar rates of venous thromboembolism and infarct-related artery patency, suggesting that the lower dose may be a preferable option due to its ease of use without compromising patient safety or outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Subcutaneous enoxaparin following thrombolysis and intravenous unfractionated heparin in ST-elevation acute myocardial infarction: safety and efficacy of low vs full dose. Rubboli, A., Gatti, C., Spinolo, L., et al.[2018]

This study evaluated the safety of low-dose unfractionated heparin (2000 to 3000 units) during intravascular ultrasound (IVUS) studies in 108 cardiac transplant patients, finding no thromboembolic events and only one minor complication (catheter-induced coronary dissection).

The results suggest that low-dose heparin can be safely administered shortly after endomyocardial biopsy during IVUS procedures, indicating its potential for use in similar clinical settings without significant adverse outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-dose unfractionated heparin administration during intravascular ultrasound studies is safe even shortly after endomyocardial biopsy in cardiac transplant patients. Arsanjani, R., Khitri, A., Hashemzadeh, M., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Unfractionated heparin during elective PCI: fixed dose or weight adjusted? [2015]

2. France pubmed.ncbi.nlm.nih.gov

Pretreatment with heparin in patients with ST-segment elevation myocardial infarction: a report from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). [2023]

3. Canada pubmed.ncbi.nlm.nih.gov

Efficacy and safety of low-dose heparin in hemodialysis. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The REDUCED (a RandomisED stUdy Comparing standard systemic anticoagulation thErapy to low Dose intracoronary anticoagulation therapy for elective percutaneous coronary intervention) trial. A novel pharmacologic regime for elective percutaneous coronary intervention. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Fondaparinux with UnfracTionated heparin dUring Revascularization in Acute coronary syndromes (FUTURA/OASIS 8): a randomized trial of intravenous unfractionated heparin during percutaneous coronary intervention in patients with non-ST-segment elevation acute coronary syndromes initially treated with fondaparinux. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Heparin or enoxaparin anticoagulation for primary percutaneous coronary intervention. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Comparison of a Fully Weight-Based Protocol with a Non-Weight-Based Dosage Titration Protocol for IV Unfractionated Heparin: A Before-and-After Study. [2023]

8. Italy pubmed.ncbi.nlm.nih.gov

Subcutaneous enoxaparin following thrombolysis and intravenous unfractionated heparin in ST-elevation acute myocardial infarction: safety and efficacy of low vs full dose. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Low-dose unfractionated heparin administration during intravascular ultrasound studies is safe even shortly after endomyocardial biopsy in cardiac transplant patients. [2019]