PEP for Post-Stent Heart Recovery

Overseen By Dereen Ernst, RN

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Christopher J. McLeod

Must not be taking: Immunosuppressants

Disqualifiers: Organ transplant, Pregnancy, HIV, others

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

Compensation: Varies

Number of Visits: 9

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a biological drug called PEP to determine its effectiveness in protecting the heart after a coronary stent placement. Researchers mix PEP into a solution and inject it to assess its ability to stop or slow heart damage. The trial targets individuals receiving a stent in their heart arteries who maintain good blood flow through the stented area post-procedure. Participants should live within 90 miles of the study site and be able to attend follow-up visits. As a Phase 1 trial, this research aims to understand how PEP works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on immunosuppressive agents for a chronic inflammatory disorder, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that the safety of PEP, a drug made from blood components, remains under study. This drug is mixed with a solution to prevent clots and then injected. In this early testing stage, the main goal is to ensure PEP's safety for individuals with a coronary stent.

Limited information exists on PEP's safety because it is still in initial trials. Researchers focus on how well people tolerate the drug and any potential side effects. During this phase, they gather safety information before assessing PEP's overall effectiveness.

Since PEP is in early testing, it may not have undergone extensive safety checks. Trial participants help researchers learn more about the treatment's safety and effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for post-stent heart recovery, which typically involve oral medications like antiplatelet drugs, PEP is unique because it is administered directly into the coronary artery right after stent placement. This one-time intracoronary infusion allows for targeted delivery exactly where it's needed, potentially reducing complications and enhancing the healing process. Researchers are excited about PEP because it might offer a more efficient and immediate way to support heart healing compared to traditional methods, promising quicker recovery and fewer side effects.

What evidence suggests that PEP might be an effective treatment for post-stent heart recovery?

Research has shown that PEP, a drug made from blood components, is under study for its potential to prevent or reduce heart damage after stent placement. In this trial, participants undergoing a percutaneous coronary intervention (PCI) and possible stent placement will receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation. Early results suggest that injecting this solution directly into the heart's artery might protect the heart. Although limited data exist on PEP's effectiveness in people, the approach uses natural materials to aid heart healing. This method aims to prevent issues like restenosis, where the artery narrows again after stent placement. Overall, PEP appears promising, but further research is needed to confirm its benefits. ^{1 3 6 7 8}

Who Is on the Research Team?

Guy S Reeder

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for people who've had a coronary stent placed and show less than 30% blockage after the procedure. Participants must be able to return for follow-ups, live within 90 miles of the study site, and give informed consent. It's not for pregnant or breastfeeding women, those with decision-making impairments, prisoners, non-English speakers, certain viral infections (like HIV), severe kidney/liver issues, low hemoglobin levels, recent drug use or major surgery/trauma.

Inclusion Criteria

Angiographic evidence of TIMI 3 flow through the stented vessel after stent placement

I am scheduled for or have had a coronary stent placement.

Willing and able to provide signed informed consent

Exclusion Criteria

My liver tests were twice as high as the normal range in the past year.

You have an allergy to heparin or a condition called heparin-induced thrombocytopenia.

I have a history of cancer, but not non-melanoma skin cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of dose limiting toxicities and myocardial infarction scar size

365 days

Multiple visits (in-person) on Day 7, Day 40, and Day 365

What Are the Treatments Tested in This Trial?

Interventions

• PEP

Trial Overview The trial tests PEP—a biological drug made from blood components—to see if it can prevent heart damage when injected into patients who have received a coronary stent. PEP is mixed with heparinized saline before being administered intracoronarily.

How Is the Trial Designed?

Group I: PEP in Coronary Stent Implantation Experimental Treatment 1 Intervention

Patients undergoing a percutaneous coronary intervention (PCI) and possible stent placement procedure will receive a one-time intracoronary infusion of PEP within 20 minutes after stent placement or post-dilation (whichever comes last).

Who Is Running the Clinical Trial?

Christopher J. McLeod

Lead Sponsor

Trials

1

Recruited

9+

Rion LLC

Collaborator

Trials

2

Recruited

20+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC59599/

Long-term outcome after coronary stenting - PMC At 5 years, BENESTENT investigators [46] reported a 34.5% rate of adverse events after stenting, and a 40.2% rate after PTCA, which represents a nonsignificant ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04327635?cond=heart&term=Extracellular%20Vesicles&rank=4

NCT04327635 | Safety Evaluation of Intracoronary Infusion ... The purpose of this study is to determine the safety of using a biological drug called PEP in people who have had a coronary stent placed.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S105017382500101X

Precision management of coronary in-stent restenosis Clinical restenosis rates are reported at 20–30 % for bare-metal stents (BMS) at six months, and 5–15 % for drug-eluting stents (DES) [[3], [4]] ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10490586/

Long term outcome after coronary stent implantation Conclusions: Long term survival and infarct free survival was good, particularly in non-diabetic men with single vessel disease and good ventricular function, ...

5. eurointervention.pcronline.com eurointervention.pcronline.com/article/paclitaxel-coated-balloon-catheter-versus-paclitaxel-coated-stent-for-the-treatment-of-coronary-in-stent-restenosis-the-three-year-results-of-the-pepcad-ii-isr-study

the three-year results of the PEPCAD II ISR study After one year, for clinical follow-up 65/66 (98.5%) patients were available in the DCB group and 63/65 (96.9%) in the DES group (p=0.62), whereas after three ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8507088/

Efficacy and safety of coronary stent intervention for ... It has been reported that coronary stent intervention is not only minimally invasive, but also effective and safe [10]. However, some studies also suggest that ...

7. eurointervention.pcronline.com eurointervention.pcronline.com/article/randomized-comparison-of-bare-metal-or-drug-eluting-stent-versus-drug-coated-balloon-in-non-st-elevation-myocardial-infarction-pepcad-nstemi

the randomised PEPCAD NSTEMI trial The results of the present study support the safety of coronary intervention without stent implantation in patients with an increased thrombotic risk. After ...

8. journal.hsforum.com journal.hsforum.com/index.php/HSF/article/view/8273

Drug-Eluting Stents and the Duration of Antiplatelet ... Emerging data indicate that shorter DAPT regimens do not elevate the risk of stent thrombosis while markedly reducing bleeding complications.