Dapansutrile for Heart Attack Recovery

JR
Overseen ByJonathan R Lindner, MD

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug called dapansutrile, which might aid recovery after a heart attack. The researchers aim to determine if it can reduce arterial plaque, lower inflammation, and improve small blood vessel function in the heart. Participants will receive either dapansutrile or a placebo (a pill with no active drug) to compare effects. Ideal candidates are those who have experienced a specific type of heart attack and received artery-clearing treatment within the last 48 hours. As an Early Phase 1 trial, this research focuses on understanding how dapansutrile works in people, offering participants the chance 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 if you need to stop taking your current medications. However, if you are using immunosuppressive medications, you may not be eligible to participate.

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

Research shows that dapansutrile, a pill, has undergone previous safety testing. A recent study found it safe and well-tolerated in patients with stable heart failure with reduced ejection fraction (HFrEF). Researchers observed patients for 14 days and reported no major safety issues. Another study demonstrated that dapansutrile reduced heart damage in animals after a heart attack. While these results are promising, this treatment remains in the early stages of testing for heart attack recovery. Further research will confirm its safety in humans.12345

Why do researchers think this study treatment might be promising for heart attack recovery?

Most treatments for heart attack recovery focus on improving blood flow or managing symptoms with medications like beta-blockers and statins. But dapansutrile works differently, targeting inflammation, which is a key contributor to heart damage post-heart attack. Researchers are excited because dapansutrile, an oral medication, specifically inhibits the NLRP3 inflammasome, potentially reducing inflammation and promoting faster, more effective recovery. This unique approach could offer a new avenue of treatment that complements existing therapies, addressing an aspect of heart attack recovery that current options don't specifically target.

What evidence suggests that dapansutrile might be an effective treatment for heart attack recovery?

Research has shown that dapansutrile, an oral medication, may reduce heart damage after a heart attack. In earlier studies, this treatment significantly decreased heart tissue damage by up to 71% when administered after blood flow restoration. This trial will compare dapansutrile to a placebo to assess its effectiveness in protecting the heart and improving recovery post-heart attack. Previous findings have demonstrated that the treatment is safe and well-tolerated in patients with heart failure. These results suggest dapansutrile might effectively aid heart healing after an attack.12345

Are You a Good Fit for This Trial?

This trial is for individuals who have had a type I heart attack and received reperfusion therapy within the last 48 hours. They must have certain levels of artery plaque or thickness to join. People with severe kidney issues, recent strokes, allergies to specific agents, pregnancy, life-threatening complications from their heart attack, certain infections or cancers can't participate.

Inclusion Criteria

I have plaque in my carotid or femoral artery, or my carotid artery wall is thick.
I have had or am scheduled for a procedure to restore blood flow within the last 2 days.
I have had a recent heart attack.

Exclusion Criteria

Pregnancy or breastfeeding
I am currently receiving or recently received treatment for cancer.
I am taking immunosuppressive drugs or have an immune deficiency.
See 12 more

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 placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

  • Dapansutrile
  • Placebo
Trial Overview The study tests if dapansutrile (an inflammasome inhibitor) affects carotid plaque volume over six months compared to a placebo in patients after an urgent heart attack treatment. It also looks at inflammation in plaques and how well small blood vessels in the heart are working.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: DapansutrileExperimental Treatment1 Intervention
Group II: ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Citations

The NLRP3 Inflammasome Inhibitor, OLT1177 ...OLT1177 treatment at reperfusion showed significant dose-dependent reduction in infarct size (−36%, −67%, and −62% for 6, 60, and 600 mg/kg, respectively; P < ...
2.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/30747785/
The NLRP3 Inflammasome Inhibitor, OLT1177 ...OLT1177 reduced infarct size also when given after 60 minutes of reperfusion (-71%, P < 0.001 vs. vehicle). Conclusion: OLT1177 (dapansutrile) limits infarct ...
The Effects of an Inflammasome Inhibitor OLT1177 on the ...Even so, thanks to medical advancements, and the continuous improvement in effective and prompt medical treatment, patients are surviving and living longer.
Phase 1B, Randomized, Double-Blinded, Dose Escalation ...Treatment with dapansutrile, an oral NLRP3 inflammasome inhibitor, was well tolerated and safe over a 14-day treatment period in patients with stable HFrEF.
The NLRP3 Inflammasome Inhibitor, OLT1177 ...OLT1177 reduced infarct size also when given after 60 minutes of reperfusion (-71%, P < 0.001 vs. vehicle). Conclusion: OLT1177 (dapansutrile) limits infarct ...
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Terms of Service·Privacy Policy·Cookies·Security