SP16 Inflammatory Response Inhibition Trial
کلید واژه ها
خلاصه
شرح
The main hypothesis of this study is that a single subcutaneous administration of SP16 0.2 mg/kg is safe and well tolerated in patients with ST segment elevation myocardial infarction (STEMI) and associated with a reduction in the acute inflammatory response to STEMI, as measured as area-under-the-curve (AUC) for C reactive protein (CRP), the preferred inflammatory marker for cardiovascular risk prognostication.
SP16 will be administered subcutaneously as this route has greater ease of administration than intravenous injection. A single dose administration has been selected based upon pre-clinical data and expected clinical use of SP16.
تاریخ
| آخرین تأیید شده: | 02/29/2020 |
| اولین ارسال: | 01/07/2020 |
| ثبت نام تخمینی ارسال شد: | 01/07/2020 |
| اولین ارسال: | 01/12/2020 |
| آخرین بروزرسانی ارسال شده: | 03/24/2020 |
| آخرین به روزرسانی ارسال شده: | 03/25/2020 |
| تاریخ شروع مطالعه واقعی: | 02/23/2020 |
| تاریخ تخمین اولیه اولیه: | 03/30/2021 |
| تاریخ برآورد مطالعه: | 03/30/2022 |
شرایط یا بیماری
مداخله / درمان
Drug: SP16
فاز
گروههای بازو
| بازو | مداخله / درمان |
|---|---|
| Experimental: SP16 Patients will receive a single dose of SP16 0.2 mg/kg by subcutaneous injection | Drug: SP16 All patients will receive a single dose of SP16 |
معیارهای صلاحیت
| جنسیت واجد شرایط مطالعه | All |
| داوطلبان سالم را می پذیرد | آره |
| شاخص | In order to be eligible for this study, patients must meet all the 3 criteria: 1. Presentation to the hospital with acute STEMI defined as chest pain (or equivalent) with an onset within 12 hours and electrocardiogram (ECG) evidence of ST segment elevation (>1 mm) in 2 or more anatomically contiguous leads that is new or presumably new (for intermittent pain lasting more than 12 hours, the time from the when the pain became severe and constant); 2. Coronary intervention planned and/or completed within 12 hours of symptom onset, and enrollment in the study within 6 hours of angiogram (max 18 hours from symptom onset) 3. Age>21 years In order to be eligible for this study, patients must meet none of the Exclusion criteria. - Inability to give informed consent - Hemodynamic instability as defined as need for inotropic or vasoactive agents, or need for mechanical support devices (including intra-aortic balloon pump) - Pregnancy or breastfeeding - Preexisting congestive heart failure (American Heart Association/American College of Cardiology class C-D, New York Heart Association III-IV) - Preexisting severe left ventricular dysfunction (LVEF<20%) - Preexisting severe valvular heart disease - Known active infections (acute or chronic) - Recent (<14 days) or active use of immunosuppressive drugs (including but not limited to high-dose corticosteroids [>1 mg/kg of prednisone equivalent], tumor necrosis factor-alpha blockers, cyclosporine) not including non-steroidal anti-inflammatory drugs (NSAIDs) or corticosteroids used for intravenous (IV) dye allergy only) - Recent (<14 days) or active use of anti-inflammatory drugs (not including NSAIDs or corticosteroids used for IV dye allergy only) - Known chronic inflammatory disease (including but not limited to rheumatoid arthritis, systemic lupus erythematosus) - Known active malignancy of any type, or prior diagnosis in the past 10 years - Neutropenia (absolute neutrophil count<1,800/mm3 [or <1,000/mm3 in African American patients]) - Severe impairment in renal function (estimated glomerular filtration rate <30 ml/kg*min) - Anticipated need for cardiac or major surgery - Known Allergy to SP16 |
نتیجه
اقدامات اولیه
1. Area under the curve (AUC) for C-reactive protein (CRP) [Baseline, 72 hours, 14 days]
اقدامات ثانویه
1. Infarct size [72 hours]
2. Change in left ventricular ejection fraction (LVEF) [90 days]
