A phase IIa, placebo-controlled, double blind, randomised multicentre pilot study to investigate the efficacy, safety and tolerability of the monoclonal antibody ATH3G10 in patients with ST-elevation myocardial infarctio
- Conditions
- Acute Heart InfarctST elevation Myocardial infarction10011082
- Registration Number
- NL-OMON48214
- Lead Sponsor
- Athera Biotechnologies AB
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 16
Patients must fulfil all of the following criteria to be included in the study:
1. Provision of informed consent
2. Symptoms and signs consistent with acute MI and ST elevation at the J-point
in two contiguous leads (cut-points: >0.2mV in men and >0.15 mV in women in
leads V2-V3 and/or >0.1 mV in other leads)
3. Start of PCI, defined as when the guide wire is passed through the stenosis,
less than 4 hours after symptom onset
4. TIMI flow grade 0 at angiography before PCI in left anterior descending
coronary artery (segment 6 or 7) without collaterals OR TIMI flow grade less
than 3 in any infarct related main coronary arteries after PCI
5. Age 40-85, inclusive
--Females must be of non-childbearing potential at screening confirmed by
fulfilling one of the following criteria a) postmenopausal defined as
amenorrhea for at least 12 months, or b) documentation of irreversible surgical
sterilization.
1. Cardiogenic chock, non-compensated acute heart failure and/or pulmonary
oedema.
2. Previous major vascular intervention within the last 4 weeks.
3. History of an infarct in the same artery that is currently affected.
4. Thrombolysis prior to admission.
5. Previous treatment with ATH3G10
6. Weight of less than 63 kg at screening (results in dose more than 4 mg/kg
body weight)7.
8. Recent (<1 month prior to screening) or current treatment with methotrexate
and/or tumour necrosis factor alpha (TNF*) inhibitors such as infliximab.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary endpoint: Left Ventricular End-Diastolic Volume index (LV EDVi) change<br /><br>from Visit 2 to Visit 3.<br /><br>Safety endpoints: Safety and tolerability: AEs/SAEs, blood pressure, physical<br /><br>examination, ECG and laboratory assessments including clinical chemistry,<br /><br>haematology and coagulation. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary endpoints: Myocardial Salvage index (MSi) at Visit 2.</p><br>