Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
TAILOR BLEED 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.Check my eligibility
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.See study design
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.
TAILOR BLEED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
TAILOR BLEED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Thrombus formation defined as AUC measured by T-TAS
Side effects data
From 2013 Phase 3 trial • 1008 Patients • NCT015153452%
Bleeding (TIMI minor)
1%
Cardiovascular death
1%
Bleeding (TIMI major)
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard Therapy
Individualized Therapy
TAILOR BLEED 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
1,341 Previous Clinical Trials
715,556 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've been on aspirin and either prasugrel or ticagrelor after a heart procedure for over 30 days.I am 18 years old or older.You are allergic to clopidogrel.I am on dialysis for kidney failure.I am not pregnant or breastfeeding and use birth control.I have a severe liver condition.My blood pressure and heart rate are not stable.I have a bleeding or clotting disorder.I am currently taking blood thinners for a blood clot.I had a heart issue, got a stent, and have been on aspirin and another heart medicine for over 3 months.You have had a stent blood clot before.
Research Study Groups:
This trial has the following groups:- Group 1: Potent P2Y12 monotherapy
- Group 2: DAPT de-escalation
Awards:
This trial has 3 awards, including:- 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.
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.
Have any fresh participants been accepted for this research project?
"Data from clinicaltrials.gov reports that this trial is not presently accepting applicants, as it was last updated on January 4th 2023 after being posted on February 15th of the same year. However, 871 other studies are in search for participants currently."
Answered by AI
How efficacious is Potent P2Y12 monotherapy in safeguarding individuals?
"Assessed on a scale of 1 to 3, the safety of Potent P2Y12 monotherapy was given an estimable score of 3 due to it being in its fourth phase. This indicates that this medication has already been approved by authorities."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger