Heparin for Heart Disease

Recruiting at 1 trial location

Overseen By Shahar Lavi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Must not be taking: Anticoagulants

Disqualifiers: Abnormal circulation, Prior thrombosis, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

3600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how different doses of heparin, a blood thinner, assist people undergoing cardiac catheterization, a procedure that checks for heart problems. Participants will be divided into three groups: one receiving a low dose of heparin, another a high dose, and the last group receiving a placebo (a substance with no active drug). The trial aims to determine heparin's effects on the heart during this procedure. Individuals undergoing this heart test with normal blood flow in their arm (ulno-palmar circulation) might be suitable for the trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes patients who require anticoagulation. This might mean you need to stop anticoagulant medications to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Heparin is a medication commonly used in hospitals to prevent blood clots. Doctors are very familiar with it due to its long history of use. Safety is crucial because heparin can be risky if not used carefully. Research has shown that patients using heparin, whether in low or high doses, did not experience more major problems compared to other treatments, indicating it is generally safe and well-tolerated.

However, like any medication, heparin can have side effects, and doctors take steps to manage them. For specific concerns, consulting a healthcare professional is advisable. They can provide detailed information about how heparin might affect an individual personally. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using heparin for heart disease because it could offer a more direct way to prevent blood clot formation, which is a major concern in heart conditions. Unlike standard treatments that often focus on managing symptoms or reducing cholesterol, heparin works by thinning the blood and directly targeting the clotting process. The trial is testing two different doses of heparin—low and high—to see which is most effective, offering potentially flexible treatment options based on patient needs. If successful, this could lead to faster and more efficient prevention of complications from heart disease, possibly providing quicker results than current standard treatments.

What evidence suggests that this trial's treatments could be effective for heart disease?

Research has shown that heparin prevents excessive blood clotting during heart procedures. For patients with sudden heart problems, studies have found that a specific amount of heparin results in the lowest death rates. Administering heparin early, especially within the first few hours of symptoms, may be more effective because it targets newer blood clots. Additionally, heparin use has been linked to reduced chances of dying from heart issues or experiencing another heart attack in some patients. In this trial, participants will receive either low-dose or high-dose heparin, or a placebo. These findings suggest that heparin, in both low and high doses, can effectively treat heart disease. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for patients needing diagnostic cardiac catheterization using a small size sheath and with good ulno-palmar blood flow. It's not suitable for those with abnormal blood flow in this area, previous radial artery clotting, surgery near the access site, urgent catheterization needs, heparin allergies or history of Heparin-Induced Thrombocytopenia (HIT), or if they already need anticoagulants.

Inclusion Criteria

A small-sized tube is used.

My hand's blood flow is normal.

I have had a heart catheterization test.

Exclusion Criteria

I need medication to prevent blood clots.

I have had surgery near the area where they plan to access my body for the trial.

I have had an urgent heart catheterization procedure.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients undergo cardiac catheterization and are randomized to receive low-dose heparin, high-dose heparin, or placebo. After 30 minutes, a gradual wrist band release is performed.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for hematoma, radial artery occlusion, and other access site complications.

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Heparin
• Placebos

Trial Overview The study is testing the effects of no anticoagulant versus low and high doses of heparin during cardiac catheterization. Patients will be randomly assigned to one of these three groups to compare outcomes.

How Is the Trial Designed?

Group I: Low dose heparin Active Control 1 Intervention

heparin (25 IU/Kg -maximal dose 3,000 IU)

Group II: High dose heparin Active Control 1 Intervention

heparin 50 IU/kg -maximal dose 5,000 IU

Group III: Placebo Placebo Group 1 Intervention

Normal saline 0.9%.

Who Is Running the Clinical Trial?

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

Published Research Related to This Trial

Low molecular weight heparins (LMWHs) offer significant advantages over unfractionated heparin (UFH) for treating venous thromboembolism (VTE) and acute coronary syndromes, including better bioavailability, longer half-life, and predictable anticoagulant effects, allowing for less frequent dosing without the need for monitoring.

UFH is associated with risks such as bleeding and heparin-induced thrombocytopenia, while LMWHs reduce these risks and improve patient convenience, highlighting the shift towards LMWHs in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives on antithrombotic agents: from unfractionated heparin to new antithrombotics. Agnelli, G., Sonaglia, F.[2005]

Enoxaparin is a viable alternative to unfractionated heparin (UFH) for treating various thrombotic conditions, showing similar or improved efficacy, but it carries a modestly increased risk of bleeding complications.

Careful dosage selection and special precautions are necessary for high-risk populations, such as elderly patients and those with renal dysfunction, to ensure safety while using enoxaparin.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety evaluation of enoxaparin in currently approved indications. Meneveau, N.[2022]

In a study involving 3,171 patients with unstable angina or non-Q wave myocardial infarction, enoxaparin was found to be more effective than unfractionated heparin in reducing the risk of recurrent angina, myocardial infarction, and death, with a significant reduction from 19.8% to 16.6% after 14 days.

While enoxaparin did not increase the overall risk of serious bleeding compared to unfractionated heparin, it was associated with a higher rate of minor bleeding complications (11.9% vs. 7.2%), indicating a need for careful monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

ESSENCE trial results: breaking new ground. Efficacy and Safety of Subcutaneous Enoxaparin in Non-Q wave Coronary Events. Demers, C.[2022]

Intravenous unfractionated heparin (UFH) effectively reduces the risk of death or heart attacks in patients with unstable angina, highlighting its importance in acute care.

Low molecular weight heparins offer improved pharmacologic properties and similar or greater clinical efficacy compared to UFH, making them a preferred treatment option due to their ease of use and lack of need for monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-molecular-weight heparin in patients with non-ST-segment elevation acute coronary syndrome: role in the emergency department. Goodman, SG.[2019]

Low-molecular-weight heparin (LMWH) offers practical advantages over unfractionated heparin in treating acute coronary syndromes, including the ability to be administered subcutaneously without the need for laboratory monitoring.

Recent randomized studies have shown that LMWH can effectively address the limitations of unfractionated heparin, improving safety and efficacy in managing patients with acute coronary syndromes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The emerging role of low-molecular-weight heparin in cardiovascular medicine. Hirsh, J., Bates, SM.[2007]

A meta-analysis of two large phase III trials showed that enoxaparin is more effective than unfractionated heparin in reducing severe cardiac events in patients with unstable angina and NSTEMI, particularly benefiting those with higher cardiac risk factors.

The study identified that patients with ST-segment deviation and elevated cardiac enzyme markers, as well as women and nonsmokers, experienced greater benefits from enoxaparin treatment, suggesting specific subgroups may respond better to this therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enoxaparin in unstable angina/non-ST-segment elevation myocardial infarction: treatment benefits in prespecified subgroups. Cohen, M., Antman, EM., Gurfinkel, EP., et al.[2019]

Unfractionated heparin (UFH) is a high-alert medication with a significant risk of drug-related problems, including harmful medication errors that account for 4.5-5.5% of reported cases, highlighting the need for improved safety measures in its administration.

UFH therapy can lead to serious complications such as heparin-induced thrombocytopenia, bleeding events, and osteopenia, with safer alternatives like low-molecular-weight heparins offering equivalent or superior efficacy for many conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unfractionated heparin: focus on a high-alert drug. Niccolai, CS., Hicks, RW., Oertel, L., et al.[2019]

In a subgroup analysis of 542 heart failure patients from the CERTIFY trial, low-molecular-weight heparin (certoparin) showed a slightly lower incidence of venous thromboembolic events compared to unfractionated heparin (UFH), suggesting it may be at least as effective for this population.

Patients with heart failure had a higher risk of developing distal deep venous thrombosis and bleeding complications, but the bleeding risk was similar between certoparin and UFH, indicating that certoparin is a safe alternative for thromboprophylaxis in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Certoparin versus unfractionated heparin to prevent venous thromboembolic events in patients hospitalized because of heart failure: a subgroup analysis of the randomized, controlled CERTIFY study. Tebbe, U., Schellong, SM., Haas, S., et al.[2017]

In a study of 210 patients with peripheral occlusive arterial disease, enoxaparin demonstrated superior efficacy compared to unfractionated heparin (UFH), with a significantly lower rate of thromboembolic complications during endovascular interventions (10.5% vs. 2.5%).

The use of enoxaparin also resulted in quicker achievement of therapeutic anti-factor Xa levels, with 63.7% of patients reaching these levels within 15 minutes, compared to only 39.1% in the UFH group, indicating a faster onset of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of enoxaparin and unfractionated heparin in endovascular interventions for the treatment of peripheral arterial occlusive disease: a randomized controlled trial. Duschek, N., Vafaie, M., Skrinjar, E., et al.[2023]

Oral heparin combined with SNAC (sodium N-(8-(2-hydroxybenzoyl)amino)caprylate) has been shown to effectively absorb therapeutic levels of heparin, making it a promising alternative to traditional parenteral administration.

This oral formulation has demonstrated efficacy in preventing venous thromboembolism after total hip replacement, indicating its potential for broader clinical use and warranting further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oral delivery of heparin: SNAC and related formulations. Pineo, G., Hull, R., Marder, V.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10225678/

Effectiveness of early heparin therapy on outcomes in critically ... Our data demonstrated that in patients with SIC, administration of 6,250–13750 IU heparin reduced ICU mortality, which may be due to the ...

2. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK538247/

Heparin - StatPearls - NCBI Bookshelf Heparin, also approved by the FDA, is used to prevent excessive coagulation during procedures such as cardiac surgery, extracorporeal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0002870302000467

Heparin dosing and outcome in acute coronary syndromes Results The lowest mortality rate appeared with a heparin dose of approximately 14 U/kg/h or an aPTT of approximately 70 seconds.

4. academic.oup.com academic.oup.com/eurheartj/article/46/39/3888/8220871

Heparin administration at first medical contact vs immediately ... To our knowledge, early UFH therapy within the first 1 or 2 h of symptom onset may be more effective,13 as the thrombus is less organized and ...

5. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.105.595397

Angiographic and Clinical Outcomes in Patients Receiving ... Treatment with LMWH was also associated with a significantly lower rate of cardiovascular death or recurrent myocardial infarction through 30 days (6.9% versus ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12059864/

Outcome and safety comparison of low-molecular-weight ... Patients with mechanical heart valves undergoing non-cardiac surgery, unfractionated heparin and LMWH showed no significant differences in efficacy or outcomes ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0753332221003462

Pharmacological and clinical application of heparin progress Heparin is one of the most widely used anticoagulants in clinical practice for preventing and treating thromboembolic diseases. Certain limitations exist (e.g., ...

8. withpower.com withpower.com/trial/phase-3-heart-diseases-9-2020-955c3

Heparin for Heart Disease A meta-analysis of two large phase III trials showed that enoxaparin is more effective than unfractionated heparin in reducing severe cardiac events in patients ...