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P2Y12 Inhibitor
Ticagrelor vs Clopidogrel for Coronary Artery Disease (SWAP-AC-2 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
Undergone successful PCI and treated with DAPT (aspirin plus a P2Y12 inhibitor) per standard of care
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 days
Awards & highlights
SWAP-AC-2 Trial Summary
This trial is testing whether the drug ticagrelor is more effective than clopidogrel in reducing the risk of thrombotic events (blood clots) in patients who are also taking oral anticoagulants (blood thinners). A total of 63 patients will be enrolled and given either ticagrelor or clopidogrel. The trial will assess the pharmacodynamic effects of both drugs to determine which is more effective.
Who is the study for?
Adults over 18 who've had successful PCI and are on dual antiplatelet therapy (aspirin plus a P2Y12 inhibitor) and an oral anticoagulant for any reason. They must not be in other drug studies, have major bleeding issues, severe liver disease, recent strokes, life-threatening non-cardiovascular diseases, end-stage renal disease on dialysis, or allergies to the study drugs.Check my eligibility
What is being tested?
The trial is testing how well two blood-thinning medications—Ticagrelor and Clopidogrel—work in patients with coronary artery disease who also need oral anticoagulation after PCI. It aims to see if one is better at preventing platelets from clumping together using a scoring system called ABCD-GENE.See study design
What are the potential side effects?
Possible side effects include bleeding problems since both Ticagrelor and Clopidogrel prevent blood clotting. There may also be risks of bruising easily, shortness of breath or allergic reactions. The exact side effects will vary between individuals.
SWAP-AC-2 Trial 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 successful heart stent placement and am on blood thinning medication.
SWAP-AC-2 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
Platelet reactivity measured as PRU
SWAP-AC-2 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: ABCD-GENE >10 - TicagrelorExperimental Treatment1 Intervention
Patients with an ABCD-GENE>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
Group II: ABCD-GENE >10 - ClopidogrelActive Control1 Intervention
Patients with an ABCD-GENE>10 score will be randomized in a 1:1 fashion to ticagrelor (60 mg/bid) or clopidogrel (75 mg/qd). Treatment will be maintained for 30 days.
Group III: ABCD-GENE <10 - ClopidogrelActive Control1 Intervention
Patients with an ABCD-GENE<10 will be treated with clopidogrel (75 mg/qd) for 30 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ticagrelor 60mg
2020
Completed Phase 4
~40
Find a Location
Who is running the clinical trial?
University of FloridaLead Sponsor
1,341 Previous Clinical Trials
715,587 Total Patients Enrolled
44 Trials studying Coronary Artery Disease
30,070 Patients Enrolled for Coronary Artery Disease
Dominick J Angiolillo, MD, PhDPrincipal InvestigatorUniversity of Florida
11 Previous Clinical Trials
1,682 Total Patients Enrolled
7 Trials studying Coronary Artery Disease
1,416 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have severe liver problems or a liver disease that affects my blood clotting.Your hemoglobin level is less than 9 mg/dL.I am currently taking a specific blood thinner (apixaban, dabigatran, edoxaban, or rivaroxaban).I have no active bleeding or history of major bleeding.I am allergic or react badly to clopidogrel or ticagrelor.I am not currently taking strong medication for fungal infections or HIV.I had a stroke caused by a blood clot within the last month.Your platelet count is less than 80,000 per microliter of blood.I have had a successful heart stent placement and am on blood thinning medication.I am on dialysis for end-stage kidney disease.I am not pregnant, breastfeeding, and if capable of becoming pregnant, I use effective birth control.I have had a bleeding stroke or brain bleed in the past.I have a serious health condition besides heart disease that could worsen with the study treatment.
Research Study Groups:
This trial has the following groups:- Group 1: ABCD-GENE >10 - Clopidogrel
- Group 2: ABCD-GENE >10 - Ticagrelor
- Group 3: ABCD-GENE <10 - Clopidogrel
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
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.
Does the FDA recognize Ticagrelor 60mg for use in patients?
"The safety of Ticagrelor 60mg has been assessed as 3, since it is a Phase 4 trial, signifying that its efficacy has already been verified."
Answered by AI
Are there any vacancies for individuals seeking to participate in this research?
"The clinical trial is currently recruiting participants, according to the latest data published on clinicaltrials.gov. The initial posting was completed on December 10th 2020 and it has undergone a subsequent update as of July 6th 2022."
Answered by AI
How many volunteers have agreed to partake in this research endeavor?
"Affirmative. The information on clinicaltrials.gov indicates that this research project is actively enrolling participants, which was initially posted on December 10th 2020 and last updated July 6th 2022. This investigation seeks 80 subjects across a single site."
Answered by AI
Have there been any other tests done with Ticagrelor at the 60mg dosage?
"Currently, there are 78 active clinical trials which investigate the efficacy of Ticagrelor 60mg with 20 in Phase 3. Located primarily in Beijing, 873 different sites around the world conduct these studies."
Answered by AI
What is the typical application of Ticagrelor 60mg?
"Ticagrelor 60mg is an appropriate therapeutic option for managing myocardial infarction, stent placement, and cerebrovascular accident."
Answered by AI
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