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Antiplatelet Agent

Antiplatelet Therapy for Cardiac Vasculopathy Post-Heart Transplant

Phase 3
Recruiting
Led By Sharon Chih
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years
Heart transplant
Must not have
Bleeding disorder
Unable to undergo coronary angiography due to glomerular filtration rate ≤30 mL/min/1.73 m^2 for non-dialysis patients
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years post transplant
Awards & highlights
Pivotal Trial

Summary

This trial will study whether a common post-heart transplant medication can prevent a condition that narrows heart arteries and leads to graft dysfunction.

Who is the study for?
The AERIAL Trial is for adults who've had a heart transplant and can give informed consent. It's not for those with allergies to aspirin or clopidogrel, recent intracranial hemorrhage, bleeding disorders, very low platelet counts, past aspirin-related stomach issues, need for antiplatelets due to other conditions, allergy to iodine contrast agents, or poor kidney function preventing coronary angiography.
What is being tested?
This trial tests if early use of antiplatelet drugs like aspirin or clopidogrel can prevent artery narrowing after heart transplants compared to a placebo. The goal is to see if this approach could work in a larger study across multiple centers.
What are the potential side effects?
Possible side effects include increased risk of bleeding and bruising more easily due to the blood-thinning properties of both aspirin and clopidogrel. Stomach irritation or ulcers may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have had a heart transplant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a bleeding disorder.
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I cannot have a heart artery test due to low kidney function and I'm not on dialysis.
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I have been on blood thinners for more than 3 months.
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I have had a solid organ transplant.
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I am taking antiplatelet medication for a reason other than heart issues.
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I cannot have a heart vessel exam because of my vein conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years post transplant
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 2 years post transplant for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Feasibility: CAV event rate
Feasibility: Compliance to treatment
Feasibility: Loss to follow up rate
+2 more
Secondary study objectives
Cardiac allograft vasculopathy
Coronary endothelial function
Coronary intimal disease
+3 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: aspirinActive Control1 Intervention
Group II: clopidogrelActive Control1 Intervention
Group III: placeboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Ottawa Heart Institute Research CorporationLead Sponsor
195 Previous Clinical Trials
93,365 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,517,938 Total Patients Enrolled
Sharon ChihPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
576 Total Patients Enrolled

Media Library

Aspirin (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT04770012 — Phase 3
Cardiac Vasculopathy Research Study Groups: aspirin, clopidogrel, placebo
Cardiac Vasculopathy Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT04770012 — Phase 3
Aspirin (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04770012 — Phase 3
~0 spots leftby Dec 2024
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