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

Trial Summary

What is the purpose of this trial?

Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

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.

What data supports the effectiveness of the drug Heparin for heart disease?

Research shows that unfractionated heparin (UFH) is effective in reducing the risk of death or heart attacks in patients with unstable angina, a type of heart disease. Additionally, low-molecular-weight heparins, which are similar to UFH, have been found to be even more effective in some cases. ^{1 2 3 4 5}

Is unfractionated heparin (UFH) generally safe for humans?

Unfractionated heparin (UFH) is a high-alert drug with potential safety concerns, including medication errors, bleeding events, and heparin-induced thrombocytopenia (a condition where the blood has a lower than normal number of platelets). Long-term use can lead to osteopenia (reduced bone density). Despite these risks, it is effective for certain conditions, but safer alternatives like low-molecular-weight heparins are available. ^{1 3 6 7 8}

How does the drug heparin differ from other treatments for heart disease?

Heparin, particularly in its low-molecular-weight form, offers advantages over traditional unfractionated heparin by being easier to administer (subcutaneously) and not requiring regular blood monitoring, while still effectively reducing the risk of heart attacks and other severe cardiac events. ^{1 2 3 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

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]

References

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

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

Enoxaparin in unstable angina/non-ST-segment elevation myocardial infarction: treatment benefits in prespecified subgroups. [2019]

3. United States 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. [2017]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Oral delivery of heparin: SNAC and related formulations. [2007]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Unfractionated heparin: focus on a high-alert drug. [2019]

7. England 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. [2023]

8. England pubmed.ncbi.nlm.nih.gov

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

9. Italy pubmed.ncbi.nlm.nih.gov

Perspectives on antithrombotic agents: from unfractionated heparin to new antithrombotics. [2005]

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

The emerging role of low-molecular-weight heparin in cardiovascular medicine. [2007]