Aptamer-4Ft

ApTOLL, also known as Aptamer-4Ft, is an investigational drug currently being studied in clinical trials for two critical cardiovascular conditions: ST-Elevation Myocardial Infarction (STEMI) and Acute Ischemic Stroke (AIS). These trials aim to assess the safety, feasibility, and potential effectiveness of ApTOLL in improving outcomes for patients with these life-threatening conditions. The studies focus on administering ApTOLL in different settings, including emergency angioplasty for STEMI patients and pre-hospital treatment for suspected stroke patients.

Table of Contents

What is APTAMER-4FT?

APTAMER-4FT, also known by its brand name ApTOLL, is a novel investigational drug being developed for the treatment of serious cardiovascular and neurological emergencies[1]. It is classified as a nucleic acid drug, which means it is made up of DNA building blocks arranged in a specific sequence[1].

Medical Conditions Treated

APTAMER-4FT is currently being studied for the treatment of two critical medical conditions:

  • ST-Elevation Myocardial Infarction (STEMI): A severe type of heart attack where one of the heart’s major arteries is blocked[1].
  • Acute Ischemic Stroke (AIS): A type of stroke caused by a blockage in the blood vessels supplying the brain[2].

How APTAMER-4FT Works

While the exact mechanism of action is still being studied, APTAMER-4FT is believed to act as a neuroprotector or cytoprotector[2]. This means it may help protect brain and heart cells from damage during a heart attack or stroke. It is thought to work by reducing inflammation and other harmful processes that occur when blood flow is suddenly cut off to these vital organs.

Administration and Dosage

APTAMER-4FT is administered as an intravenous (IV) injection or bolus. In current clinical trials, it is being tested at doses of 0.2 mg/kg and 0.4 mg/kg body weight[1][2]. The drug is given as a single dose in emergency situations, typically within hours of symptom onset.

Ongoing Clinical Trials

APTAMER-4FT is currently being evaluated in two main clinical trials:

  1. STEMI Trial: This is a Phase IIa trial studying the safety and efficacy of ApTOLL in patients with ST-Elevation Myocardial Infarction. The study aims to enroll 120 patients who will receive either ApTOLL or a placebo before undergoing emergency angioplasty[1].
  2. Acute Ischemic Stroke Trial: This is a pilot study investigating the use of ApTOLL in patients with suspected acute ischemic stroke. The unique aspect of this trial is that it’s testing the drug’s administration in the pre-hospital setting, such as in ambulances[2].

Potential Benefits

The potential benefits being investigated for APTAMER-4FT include:

  • Reduction in heart damage after a heart attack[1]
  • Improvement in heart function following a heart attack[1]
  • Reduction in brain damage after a stroke[2]
  • Improvement in neurological outcomes after a stroke[2]
  • Potential to be administered very early in the course of a heart attack or stroke, possibly even before reaching the hospital[2]

Safety and Side Effects

As APTAMER-4FT is still in clinical trials, its full safety profile is not yet established. The ongoing studies are closely monitoring for any adverse events, with particular attention to:

  • Severe hypotension (very low blood pressure)
  • Sustained ventricular arrhythmias (abnormal heart rhythms)
  • Cardiogenic shock (a condition where the heart can’t pump enough blood to meet the body’s needs)
  • Bleeding complications[1][2]

It’s important to note that as with any investigational drug, there may be unknown risks and side effects that have not yet been identified.

Future Prospects

If the current clinical trials show promising results, APTAMER-4FT could potentially become a valuable new treatment option for patients experiencing heart attacks or strokes. Its ability to be administered quickly, possibly even before reaching the hospital, could make it particularly useful in emergency situations where every minute counts[2].

However, it’s important to remember that APTAMER-4FT is still in the experimental stages. More research is needed to fully understand its effectiveness and safety before it can be considered for widespread use. Patients should always consult with their healthcare providers about the most appropriate treatments for their individual situations.

Aspect STEMI Trial Acute Ischemic Stroke Trial
Drug Name ApTOLL (Aptamer-4Ft) ApTOLL (Aptamer-4Ft)
Condition ST-Elevation Myocardial Infarction (STEMI) Acute Ischemic Stroke (AIS)
Trial Phase Phase IIa Pilot Study
Dosage 0.2 mg/kg or 0.4 mg/kg 0.2 mg/kg
Administration Intravenous bolus before angioplasty Intravenous in pre-hospital setting
Primary Objectives Safety assessment Feasibility of pre-hospital administration
Key Measurements Infarct volume, cardiac function, biomarkers Enrollment metrics, patient outcomes, safety
Follow-up Period 90 days 90 days

Ongoing Clinical Trials on Aptamer-4Ft

  • Study on the Safety and Effectiveness of ApTOLL for Patients with ST Elevation Myocardial Infarction (STEMI)

    Not yet recruiting

    2 1
    Investigated drugs:
    Spain
  • Study of ApTOLL for Treating Acute Ischemic Stroke in Patients Before Hospital Arrival

    Not yet recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Spain

Glossary

  • STEMI: ST-Elevation Myocardial Infarction: A severe type of heart attack where one of the heart's major arteries is blocked.
  • Acute Ischemic Stroke (AIS): A sudden interruption in the blood supply to part of the brain, causing a lack of oxygen to brain tissue.
  • Angioplasty: A procedure to open blocked arteries and restore blood flow to the heart.
  • RACE Scale: Rapid Arterial oCclusion Evaluation Scale: A tool used by emergency services to quickly assess the likelihood of a large vessel occlusion stroke.
  • Large Vessel Occlusion (LVO): A type of ischemic stroke caused by a blockage in one of the major arteries of the brain.
  • Intravenous (IV) bolus: A method of giving medication where a drug is injected into a vein over a short period of time.
  • Modified Rankin Scale (mRS): A scale used to measure the degree of disability in patients who have had a stroke.
  • NIHSS: National Institutes of Health Stroke Scale: A tool used to objectively quantify the impairment caused by a stroke.
  • MRI-FLAIR: Magnetic Resonance Imaging – Fluid-Attenuated Inversion Recovery: A type of MRI scan used to assess brain damage in stroke patients.
  • Proinflammatory markers: Substances in the blood that indicate the presence of inflammation in the body.

References

  1. http://clinicaltrials.eu/trial/study-on-the-safety-and-effectiveness-of-aptoll-for-patients-with-st-elevation-myocardial-infarction-stemi/
  2. http://clinicaltrials.eu/trial/study-of-aptoll-for-treating-acute-ischemic-stroke-in-patients-before-hospital-arrival/