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Antiplatelet Agent

Antiplatelet Therapy for Coronary Artery Disease (TAILOR BLEED Trial)

Phase 4
Recruiting
Led By Dominick J Angiolillo, MD,PhD
Research Sponsored by University of Florida
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥18 years old
Be older than 18 years old
Must not have
Renal failure requiring dialysis
Known severe hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial tested 2 strategies to reduce bleeding while preserving efficacy in heart attack patients who had angioplasty. Both strategies have been successful and changed practice guidelines to consider them.

Who is the study for?
This trial is for adults over 18 who have had a coronary procedure (PCI) and been on dual antiplatelet therapy with aspirin and either prasugrel or ticagrelor for at least 30 days to over 3 months. It's not for those with past stent thrombosis, on oral anticoagulants, dialysis patients, liver issues, bleeding disorders, unstable health conditions, allergy to clopidogrel or women who are pregnant/breastfeeding unless using birth control.
What is being tested?
The study tests two strategies in patients after PCI: switching from stronger blood thinners (prasugrel/ticagrelor) to a milder one (clopidogrel) while keeping aspirin; versus continuing the strong blood thinner alone without aspirin. The goal is to see which method better reduces bleeding without losing effectiveness.
What are the potential side effects?
Possible side effects include increased risk of bleeding due to the medications' effect on clotting. There may also be allergic reactions or other drug-specific side effects like bruising easily, nosebleeds, gastrointestinal discomforts such as stomach pain or diarrhea.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on dialysis for kidney failure.
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I have a severe liver condition.
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My blood pressure and heart rate are not stable.
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I have a bleeding or clotting disorder.
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I am currently taking blood thinners for a blood clot.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Thrombus formation defined as AUC measured by T-TAS

Side effects data

From 2013 Phase 3 trial • 1008 Patients • NCT01515345
2%
Bleeding (TIMI minor)
1%
Cardiovascular death
1%
Bleeding (TIMI major)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Therapy
Individualized Therapy

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Potent P2Y12 monotherapyExperimental Treatment1 Intervention
Potent P2Y12 inhibitor with prasugrel 10 mg od or ticagrelor 90 mg BID.
Group II: DAPT de-escalationActive Control1 Intervention
Aspirin 81-mg od and clopidogrel 75-mg qd.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
prasugrel or ticagrelor
2011
Completed Phase 3
~1010

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,397 Previous Clinical Trials
766,970 Total Patients Enrolled
44 Trials studying Coronary Artery Disease
30,060 Patients Enrolled for Coronary Artery Disease
Dominick J Angiolillo, MD,PhDPrincipal InvestigatorUniversity of Florida College of Medicine Jacksonville
4 Previous Clinical Trials
245 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
245 Patients Enrolled for Coronary Artery Disease

Media Library

Aspirin (Antiplatelet Agent) Clinical Trial Eligibility Overview. Trial Name: NCT05681702 — Phase 4
Coronary Artery Disease Research Study Groups: Potent P2Y12 monotherapy, DAPT de-escalation
Coronary Artery Disease Clinical Trial 2023: Aspirin Highlights & Side Effects. Trial Name: NCT05681702 — Phase 4
Aspirin (Antiplatelet Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05681702 — Phase 4
~4 spots leftby Dec 2024
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