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

9 Participants Needed

Trial Summary

What is the purpose of this trial?

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. A biological drug is a substance that is made from a living organism or its products (parts). In this case, PEP is made of certain parts of blood from living blood donors obtained from a certified blood bank. PEP comes in a powder form and is mixed with heparinized saline (a solution used to prevent clots in catheters) to create a solution that can be injected. The investigators want to see if PEP can be used to stop or slow heart damage.

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.

What data supports the effectiveness of the treatment PEP for post-stent heart recovery?

Research shows that rehabilitation exercises after heart procedures like stent placement can help improve heart function and reduce future heart problems. This suggests that treatments involving exercise, like PEP, might be beneficial for heart recovery. ^{1 2 3 4 5}

Is PEP for Post-Stent Heart Recovery safe for humans?

The research articles provided do not contain specific safety data for PEP for Post-Stent Heart Recovery. However, they discuss the safety of related treatments like clopidogrel and antiplatelet therapy after stent procedures, indicating no additional safety concerns in those contexts. ^{6 7 8 9 10}

How does the PEP treatment differ from other treatments for post-stent heart recovery?

PEP treatment is unique because it involves postconditioning, a process that protects the heart by limiting damage during the initial phase of blood flow restoration after a blockage. This approach targets mitochondrial pathways to reduce heart muscle damage, which is different from standard treatments that primarily focus on restoring blood flow. ^{11 12 13 14 15}

Research Team

Guy S Reeder

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Early Hospital Discharge Following PCI for Patients With STEMI. [2022]

2. China pubmed.ncbi.nlm.nih.gov

Effect analysis of kinetic energy progressive exercise in patients with acute myocardial infarction after percutaneous coronary intervention: a randomized trial. [2021]

3. France pubmed.ncbi.nlm.nih.gov

Clinical results of two year dual antiplatelet therapy after primary percutaneous coronary intervention with paclitaxel-eluting stents: a single centre study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Chronic thromboembolic pulmonary hypertension and the post-pulmonary embolism (PE) syndrome. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Antithrombotic therapy in cardiac stent patients. [2019]

6. Japan pubmed.ncbi.nlm.nih.gov

Japanese postmarketing surveillance of clopidogrel in patients with non-ST-segment elevation acute coronary syndrome, stable angina, old myocardial infarction, and ST-segment elevation myocardial infarction after percutaneous coronary intervention in a real-life setting: the final report (J-PLACE Final). [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of Same-Day Discharge After Percutaneous Coronary Intervention in Selected Patients With Non-ST Elevation Acute Coronary Syndrome. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Considerations in patients receiving oral antiplatelet therapy after acute coronary syndrome and percutaneous coronary intervention. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Effect of Perioperative Antiplatelet Therapy on Outcomes in Patients With Drug-Eluting Stents Undergoing Elective Noncardiac Surgery. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Next day discharge after elective intracranial aneurysm coiling: is it safe? [2018]

11. England pubmed.ncbi.nlm.nih.gov

Adenosine triphosphate postconditioning is associated with better preserved global and regional cardiac function during myocardial ischemia and reperfusion: a speckle tracking imaging-based echocardiologic study. [2017]

12. England pubmed.ncbi.nlm.nih.gov

Heart rate limitation and cardiac unloading in sevoflurane post-conditioning. [2018]

13. United States pubmed.ncbi.nlm.nih.gov

Cardiac postconditioning. [2013]

14. England pubmed.ncbi.nlm.nih.gov

New and revisited approaches to preserving the reperfused myocardium. [2019]

15. Poland pubmed.ncbi.nlm.nih.gov

[The endogenous cardioprotection during reperfusion in acute myocardial infarction]. [2020]