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Heparin for Heart Disease

Phase 3
Recruiting
Research Sponsored by Lawson Health Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnostic cardiac catheterization
Be older than 18 years old
Must not have
Patients requiring anticoagulation
Prior surgery close to the access site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 hours
Awards & highlights
Pivotal Trial
All Individual Drugs Already Approved
Approved for 20 Other Conditions

Summary

This trial will study whether different doses of anticoagulants given to patients during cardiac catheterization affects the rate of thrombotic complications.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects from heparin may include bleeding complications, allergic reactions, and possibly thrombocytopenia (a decrease in platelets which can affect clotting). The placebo group should not experience these side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had a heart catheterization test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need medication to prevent blood clots.
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I have had surgery near the area where they plan to access my body for the trial.
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I have had an urgent heart catheterization procedure.
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I have had a blood clot in the artery of my wrist before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
hematoma
radial artery occlusion
Secondary study objectives
access site bleeding
access site complications
non access site bleeding
+2 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Low dose heparinActive Control1 Intervention
heparin (25 IU/Kg -maximal dose 3,000 IU)
Group II: High dose heparinActive Control1 Intervention
heparin 50 IU/kg -maximal dose 5,000 IU
Group III: PlaceboPlacebo Group1 Intervention
Normal saline 0.9%.

Find a Location

Who is running the clinical trial?

Lawson Health Research InstituteLead Sponsor
680 Previous Clinical Trials
418,333 Total Patients Enrolled

Media Library

Low dose heparin Clinical Trial Eligibility Overview. Trial Name: NCT04374799 — Phase 3
Cardiovascular Disease Research Study Groups: Low dose heparin, High dose heparin, Placebo
Cardiovascular Disease Clinical Trial 2023: Low dose heparin Highlights & Side Effects. Trial Name: NCT04374799 — Phase 3
Low dose heparin 2023 Treatment Timeline for Medical Study. Trial Name: NCT04374799 — Phase 3
~505 spots leftby Aug 2025
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