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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
Must not have
Recent (< 6 months) type I myocardial infarction
Anticipated concomitant oral or intravenous therapy with strong cytochrome P450 3A4 (CYP3A4) inhibitors or CYP3A4 substrates with narrow therapeutic indices that cannot be stopped for the course of the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 days
Awards & highlights
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I had a heart attack within the last 6 months.
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I am not taking strong medication that affects liver enzymes and can't be stopped.
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I am on dialysis for kidney failure.
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I am on long-term blood thinners for clot treatment, not prevention.
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I have a severe liver condition.
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I am currently experiencing uncontrolled bleeding.
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I have not had a brain bleed, significant GI bleed in the last 6 months, or major surgery in the last 30 days.
Select...
I have a bleeding or clotting disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
P2Y12 reaction units (PRU)
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
4,352 Previous Clinical Trials
288,646,704 Total Patients Enrolled
63 Trials studying Coronary Artery Disease
112,890 Patients Enrolled for Coronary Artery Disease
University of FloridaLead Sponsor
1,380 Previous Clinical Trials
762,290 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:- 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.
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