Prasugrel + Clopidogrel for Coronary Artery Disease

Overseen By Andrea Burton, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Florida

Must be taking: Aspirin, Clopidogrel

Must not be taking: Oral anticoagulants, Heparin

Disqualifiers: Cerebrovascular event, Hemodynamic instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether switching to a low dose of prasugrel (an antiplatelet medication) reduces platelet reactivity more effectively than the usual dose of clopidogrel in individuals with coronary artery disease who have had a stent placed. It targets those at higher risk of both bleeding and cardiovascular issues. Individuals who have had a stent placed and have been on a daily regimen of aspirin and clopidogrel for over a month may qualify for this study. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective treatment benefits a broader range of patients.

Will I have to stop taking my current medications?

If you are currently taking clopidogrel and low-dose aspirin as part of your treatment, you may need to switch from clopidogrel to prasugrel for this trial. The protocol does not specify stopping other medications, but you should discuss your current medications with the trial team.

What is the safety track record for prasugrel and clopidogrel?

Research shows that clopidogrel is generally easy for most people to tolerate. One study found it reduced major bleeding from 1.54% to 0.41% over a year. Clopidogrel also lowers the risk of serious heart problems, such as heart attacks and issues with stents after procedures.

Prasugrel is another treatment option considered safe for people with heart conditions. Studies have found that using a lower dose of prasugrel reduces bleeding risks compared to longer treatment periods, without increasing the chance of heart-related problems.

Both treatments have demonstrated safety. However, because individuals can respond differently, discussing these options with a healthcare provider is important. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for coronary artery disease, like clopidogrel-based dual antiplatelet therapy (DAPT), aim to prevent blood clots but come with a risk of bleeding. However, prasugrel stands out because it offers a potentially more balanced approach to managing both bleeding and ischemic risks, especially when used in a low-dose DAPT regimen. Researchers are excited about prasugrel because it might offer better protection for patients who are at high risk for both bleeding and ischemic events. By targeting these dual risks more precisely, prasugrel could provide an alternative for patients who need effective blood clot prevention without significantly increasing their risk of bleeding.

What evidence suggests that this trial's treatments could be effective for coronary artery disease?

In this trial, participants will be assigned to different treatment arms to evaluate the effectiveness of dual antiplatelet therapy (DAPT) using either clopidogrel or prasugrel. Research has shown that combining clopidogrel with another blood-thinning medication can effectively reduce serious health issues, including lowering major bleeding from 1.54% to 0.41% over a year. It also outperforms aspirin alone after heart procedures to open blocked arteries. Meanwhile, this trial studies prasugrel, particularly at a lower dose, for its potential to reduce the risk of serious problems by 49% in people with acute coronary syndrome (ACS). This suggests that prasugrel might better balance preventing clots and reducing bleeding risk. Both treatments in this trial aim to manage heart conditions by lowering the chances of heart attacks and strokes. ^{1 2 3 6 7}

Who Is on the Research Team?

Dominick J Angiolillo, MD, PhD

Principal Investigator

University of Florida College of Medicine - Jacksonville

Luis Ortega-Paz, MD, PhD

Principal Investigator

University of Florida College of Medicine - Jacksonville

Are You a Good Fit for This Trial?

This trial is for heart disease patients with high bleeding and ischemic risk who have undergone a procedure called PCI. They must meet specific criteria indicating they're at dual-risk for complications post-PCI.

Inclusion Criteria

Provide written informed consent

I am at high risk for bleeding, have had a PCI, and been on aspirin and clopidogrel for over 30 days.

I am 18 years old or older.

Exclusion Criteria

Prior cerebrovascular event

I had a heart procedure within the last 30 days.

My blood pressure and heart rate are stable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either low-dose prasugrel-based DAPT or continue with clopidogrel-based DAPT

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for platelet reactivity and safety after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Clopidogrel
• Prasugrel

Trial Overview The study tests if switching from standard-dose Clopidogrel to low-dose Prasugrel is better than continuing on Clopidogrel in managing platelet reactivity, which affects blood clotting, in high-risk heart patients after PCI.

How Is the Trial Designed?

Group I: Dual risk - Low-dose prasugrel-based DAPT Experimental Treatment 1 Intervention

Patients deemed at high risk for both bleeding and ischemic risk randomized to receive low-dose prasugrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.

Group II: Dual risk - Clopidogrel-based DAPT Experimental Treatment 1 Intervention

Patients deemed at high risk for both bleeding and ischemic risk randomized to continue clopdiogrel-based DAPT. High bleeding riks will be defined according to the Academic Research Consortium definition, while high ischemic risk will be defined as those patients with an ABCD-GENE score of 10 or higher.

Group III: Control Active Control 1 Intervention

Patients deemed at high risk for both bleeding but not at high risk for ischemic events being actively treated with clopidogrel-based DAPT as per standard of care. High bleeding riks will be defined according to the Academic Research Consortium definition.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7584687/

Dual Antiplatelet Therapy in Coronary Artery Disease - PMC The results demonstrated that prolonged DAPT with either dose of ticagrelor reduced ischemic events (for 60 mg dose HR = 0.84; 95% CI 0.74–0.95; p = 0.004) MACE ...

2. jacc.org jacc.org/doi/10.1016/j.jacc.2023.11.004

Clopidogrel for Long-Term Secondary Prevention After ... Net adverse clinical event rate was significantly reduced along with a significant reduction in major bleeding from 1.54% to 0.41% at 12 months ...

3. ahajournals.org ahajournals.org/doi/10.1161/JAHA.122.027055

Long‐Term Outcomes and Duration of Dual Antiplatelet ... DAPT discontinuation after 9 months following PCI was associated with lower risks of death (HR, 0.93 [95% CI, 0.88–0.99]), cardiac death (HR, ...

4. acc.org acc.org/About-ACC/Press-Releases/2025/03/30/15/43/Clopidogrel-Outperforms-Aspirin-Monotherapy

Clopidogrel Outperforms Aspirin Monotherapy Following PCI After a median of 2.3 years, 4.4% of those taking clopidogrel and 6.6% of those taking aspirin experienced the composite primary endpoint. This ...

5. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2817471

Extended Clopidogrel Monotherapy vs DAPT in Patients ... This randomized clinical trial evaluates clopidogrel monotherapy vs dual antiplatelet therapy in patients with acute coronary syndromes ...

6. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.121.011536

Versus Short-Term Dual Antiplatelet Therapy Duration in ... DAPT>12-month versus ≤12-month DAPT was associated with a significant reduced risk of 3-year primary outcome (2.6% versus 4.6%; adjusted hazard ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S155383892500291X

pci patients: An updated systematic review and meta-analysis Clopidogrel is associated with reduction in major adverse cardiovascular events as compared to aspirin in post-PCI patients.