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Antiplatelet Agent
Ticagrelor + Aspirin for Coronary Artery Disease (OPTIMUS-7 Trial)
Phase 4
Waitlist Available
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
Men or women ≥18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
OPTIMUS-7 Trial Summary
This trial will compare the effects of ticagrelor with and without aspirin on CAD patients, compared to a standard regimen of aspirin and clopidogrel.
Who is the study for?
Adults with type 2 diabetes and a history of heart procedures (PCI) can join this trial. They must be on standard antiplatelet therapy, not have severe anemia, active bleeding, or allergies to the study drugs. They also need functioning kidneys, stable blood platelets, no recent major bleeds or surgeries, and cannot be pregnant or require certain other medications.Check my eligibility
What is being tested?
The trial is testing if ticagrelor alone is as effective as when it's combined with aspirin in people with diabetes after heart stent placement. It compares these two approaches against a common treatment combo: clopidogrel plus aspirin.See study design
What are the potential side effects?
Possible side effects include increased risk of bleeding, allergic reactions to the medications involved, potential for bruising or bleeding more easily than normal due to the antiplatelet effect of the drugs.
OPTIMUS-7 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
OPTIMUS-7 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
P2Y12 reaction units (PRU)
OPTIMUS-7 Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: TicagrelorExperimental Treatment1 Intervention
ticagrelor 60 mg bid monotherapy
Group II: Aspirin plus ClopidogrelActive Control1 Intervention
aspirin 81 mg qd plus clopidogrel 75 mg qd
Group III: Aspirin plus TicagrelorActive Control1 Intervention
aspirin 81 mg qd plus ticagrelor 60 mg bid
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Who is running the clinical trial?
AstraZenecaIndustry Sponsor
4,262 Previous Clinical Trials
288,595,137 Total Patients Enrolled
63 Trials studying Coronary Artery Disease
112,890 Patients Enrolled for Coronary Artery Disease
University of FloridaLead Sponsor
1,340 Previous Clinical Trials
715,600 Total Patients Enrolled
44 Trials studying Coronary Artery Disease
30,045 Patients Enrolled for Coronary Artery Disease
Dominick J Angiolillo, MD,PhDPrincipal InvestigatorUniversity of Florida
4 Previous Clinical Trials
230 Total Patients Enrolled
4 Trials studying Coronary Artery Disease
230 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treating my type 2 diabetes with medication for at least a month.Your platelet count is less than 80,000 per microliter of blood.I had a heart attack within the last 6 months.I have coronary artery disease and have had a stent placed, currently on medication like aspirin or clopidogrel.Your hemoglobin level is less than 9 grams per deciliter.I am not taking strong medication that affects liver enzymes and can't be stopped.You are allergic to aspirin, ticagrelor, or clopidogrel.I am on dialysis for kidney failure.I am on long-term blood thinners for clot treatment, not prevention.I have not had a heart stent placed in the last 6 months.I have a severe liver condition.I am currently experiencing uncontrolled bleeding.I have not had a brain bleed, significant GI bleed in the last 6 months, or major surgery in the last 30 days.I am 18 years old or older.I have a bleeding or clotting disorder.You have certain heart conditions that can cause slow heart rate, unless you have a pacemaker to treat it.
Research Study Groups:
This trial has the following groups:- Group 1: Ticagrelor
- Group 2: Aspirin plus Clopidogrel
- Group 3: Aspirin plus Ticagrelor
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.
Is this a brand new trial?
"As of now, 203 trials for Ticagrelor monotherapy are underway in 1414 cities and 58 nations. The initial trial, sponsored by Abbott and beginning in 2005, involved 15480 participants as it progressed through Phase 4 drug approval. Since then 832 further studies have been carried out."
Answered by AI
What is the participant intake for this clinical research?
"Affirmative. According to clinicaltrials.gov records, this medical trial is currently looking for suitable participants, having been posted on March 31st 2021 and most recently updated May 31st 2022. 63 patients are required from a single site of recruitment."
Answered by AI
For what medical reasons is Ticagrelor monotherapy commonly prescribed?
"Ticagrelor monotherapy is traditionally used to treat endarterectomy and carotid conditions. It can also be prescribed for fever, stroke, recurrent symptoms, as well as peripheral arterial disease."
Answered by AI
Has Ticagrelor been granted approval for single-drug treatment by the FDA?
"With this being a Phase 4 trial, which signals an approved therapy, we have assigned Ticagrelor monotherapy a safety rating of 3."
Answered by AI
Is there still availability for volunteers to join this research?
"Per the clinicaltrials.gov database, this research endeavour initiated on March 31st 2021 and is currently accepting participants. The most recent update to its details occurred on May 31st 2022."
Answered by AI
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