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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 and 2 years post transplant
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have had a heart transplant.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 and 2 years post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 and 2 years post transplant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility: CAV event rate
Feasibility: Compliance to treatment
Feasibility: Loss to follow up rate
+2 moreSecondary outcome measures
Cardiac allograft vasculopathy
Coronary endothelial function
Coronary intimal disease
+3 moreTrial 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
188 Previous Clinical Trials
92,301 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,282 Total Patients Enrolled
Sharon ChihPrincipal InvestigatorOttawa Heart Institute Research Corporation
1 Previous Clinical Trials
576 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a bleeding disorder.I cannot have a heart artery test due to low kidney function and I'm not on dialysis.I am 18 years old or older.I have been on blood thinners for more than 3 months.You had bleeding inside your head in the last 14 days.I have had a heart transplant.You are allergic to or cannot tolerate aspirin.I have had a solid organ transplant.You are allergic to or cannot tolerate clopidogrel.Your platelet count is less than 50,000 per microliter of blood.You have had bleeding or ulcers in your stomach related to taking aspirin in the past.I am taking antiplatelet medication for a reason other than heart issues.You are allergic to iodine-based dye used for medical tests.I cannot have a heart vessel exam because of my vein conditions.
Research Study Groups:
This trial has the following groups:- Group 1: aspirin
- Group 2: clopidogrel
- Group 3: placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many research subjects will be included in this investigation?
"The clinical trial is still open for recruitment, as of February 10th, 2022. This study was first posted on June 28th, 2021 and is looking for 135 patients from 3 locations."
Answered by AI
When was aspirin cleared by the FDA?
"Aspirin is considered safe based on available data from Phase 3 clinical trials."
Answered by AI
Is aspirin a common medication used in clinical trials?
"The aspirin clinical trials began in 2002 at Institut Curie Hopital. So far, 18924 studies have been completed with 205 currently active. Many of the ongoing research projects are based out of Vancouver, British Columbia."
Answered by AI
Are there any patients who have not yet been enrolled in this research study?
"That is correct. As of February 10th, 2022, this study was still actively recruiting patients according to information found on clinicaltrials.gov. This research project was first posted on June 28th, 2021 and is enrolling 135 individuals from 3 locations."
Answered by AI
What is the eventual goal of this clinical trial?
"The primary goal of this trial is to assess the feasibility of the treatment over a 3-year period. Secondary outcomes include measures of cardiac allograft vasculopathy, coronary macrovascular function, and platelet function."
Answered by AI
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