BridgeMD
A Masked, Multicentre, Placebo-controlled, Randomized Phase IIa Clinical Trial to investigate the safety and efficacy of ApTOLL in a population of ST Elevation Myocardial Infarct (STEMI) patients.
EU CTIS ID: 2023-503751-97-00
What this study is testing
To assess ApTOLL safety at two different doses administered by i.v. bolus (0.2 mg/kg and 0.4 mg/kg) in patients who are candidates for emergency angioplasty in the setting of ST-segment elevation myocardial infarction (STEMI) and who have not received thrombolytics.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Informed consent obtained from subject or acceptable subject surrogate (i.e., next of kin, or legal representative).
- 2. Men or Women aged ≥18 years.
- 3. In case of women of childbearing potential (WOCBP), they must confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included. Additionally, those WOCBP enrolled in the trial should adopt highly effective methods for birth control for a period of 7 days after dose. In case of male patients, partners of WOCBP, they must adopt highly effective methods for birth control for a period of 7 days after dose.
- 4. Patient admitted with primary ACS with final diagnosis of first STEMI (defined by the 2017 European Society of Cardiology [ESC] guidelines[1] for STEMI based on clinical and ECG criteria* (ST-elevation in anterior wall), within 6 hours from symptom onset, who do not receive thrombolytic therapy for the treatment of STEMI. *ECG criteria for STEMI:persistent ST-elevation in anterior wall at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads).
- 5. Patients who are suitable candidates to receive pPCI for STEMI management.
You likely can't join if
- 1. Subject has suffered an acute myocardial infarction (AMI) in the past.
- 10. Patients currently receiving, immunosupressant drugs and/or, high doses or long-term treatment with corticosteroids.
- 11. Current severe hepatic disease.
- 12. Known hemorrhagic diathesis, coagulation factor deficiency.
- 13. Unable to receive antithrombotic therapy clinically recommended.
- 14. Baseline blood glucose of <50 mg/dL or >400 mg/dL.
See the full eligibility criteria
Who can join
- 1. Informed consent obtained from subject or acceptable subject surrogate (i.e., next of kin, or legal representative).
- 2. Men or Women aged ≥18 years.
- 3. In case of women of childbearing potential (WOCBP), they must confirm menstrual period and a negative highly sensitive urine or serum pregnancy test to be included. Additionally, those WOCBP enrolled in the trial should adopt highly effective methods for birth control for a period of 7 days after dose. In case of male patients, partners of WOCBP, they must adopt highly effective methods for birth control for a period of 7 days after dose.
- 4. Patient admitted with primary ACS with final diagnosis of first STEMI (defined by the 2017 European Society of Cardiology [ESC] guidelines[1] for STEMI based on clinical and ECG criteria* (ST-elevation in anterior wall), within 6 hours from symptom onset, who do not receive thrombolytic therapy for the treatment of STEMI. *ECG criteria for STEMI:persistent ST-elevation in anterior wall at the J-point in two contiguous leads with the cut-off points: ≥0.2 millivolt (mV) in men or ≥0.15 mV in women in leads V2-V3 and/or ≥0.1 mV in other leads).
- 5. Patients who are suitable candidates to receive pPCI for STEMI management.
What rules you out
- 1. Subject has suffered an acute myocardial infarction (AMI) in the past.
- 10. Patients currently receiving, immunosupressant drugs and/or, high doses or long-term treatment with corticosteroids.
- 11. Current severe hepatic disease.
- 12. Known hemorrhagic diathesis, coagulation factor deficiency.
- 13. Unable to receive antithrombotic therapy clinically recommended.
- 14. Baseline blood glucose of <50 mg/dL or >400 mg/dL.
- 15. Evidence of active systemic infection.
- 16. Known current use of cocaine at time of treatment.
- 17. Patient participating in a study involving an investigational drug or device.
- 18. Patients that are unlikely to be available for a clinical follow-up (e.g., no fixed home address, visitor from other country).
- 19. Female who is pregnant or lactating or has a positive pregnancy test at time of admission or WOCBP who are not using an effective method of contraception.
- 2. ECG pattern of damage in another wall than anterior wall.
- 20. History of life-threatening allergy (more than rash) to contrast medium.
- 21. Known renal insufficiency with creatinine ≥3 mg/dL or Glomerular Filtration Rate (GFR) <30 mL/min. Creatinine clearance <30 mL/min/1.73 m2.
- 22. Serious, advanced, or terminal illness with anticipated life expectancy of less than 1 year.
- 3. Subjects with any other structural cardiac disease.
- 4. Subjects in cardiogenic shock stages C, D, or E of the SCAI (Society for Cardiovascular Angiography and Interventions) classification.
- 5. Subjects with cardiac arrest in the presentation of the acute myocardial infarction, requiring prolonged advanced life support resuscitation.
- 6. Past history of heart failure in NYHA (New York Heart Association) stages III or IV.
- 7. Patients with pacemaker rhythm or complete left bundle-branch block.
- 8. Suspected aortic dissection, presumed septic embolus, or suspicion of bacterial endocarditis or any other suspected non-type 1 myocardial infarction according to the Universal Definition of Myocardial Infarction.
- 9. Subjects with any contraindications related to the cardiac MRI procedure (devices or metal foreign bodies, including pacemaker, defibrillator) including severe claustrophobia according to the lists/safety rules of the local MRI departments.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.