Concomitant Therapy. This study is a comparison of standard care plus levosimendan to standard care plus placebo for the treatment of subjects in the immediate perioperative period. All patients should receive standard evidenced based therapies as recommended in local clinical practice guidelines. The patient’s regular per oral concomitant treatments (diuretics, digitalis, ACE inhibitors, nitrates, beta-blockers, and other medications e.g. antibiotics and analgesics) can be administered according to the investigator’s clinical judgment, All subjects may receive additional standard of care medications including inotropes, pressors, vasopressin, antiarrhythmics, diuretics, nitrates, and nitric oxide as needed. Due to the potentially hypotensive effects of the study drug, the concomitant use of vasodilatory active drugs should be used with caution as per the following guidance. Concomitant administration of nesiritide is not permitted; levosimendan should not be initiated within an hour of discontinuing nesiritide therapy.
Concomitant Therapy. Concomitant medications will be summarized for the safety population.
Concomitant Therapy. The use of any concomitant medication, prescription or over-the-counter, is to be recorded on the subject’s electronic case report form (eCRF) at each visit, along with the reason the medication is taken, the dates of administration, and the dose.
Concomitant Therapy. 6.3.1 Cyclosporin A CsA can be continued, if already administered prior to screening. CsA can be withdrawn at any time, upon the judgement of the Investigator. CsA is not to be introduced de novo during the course of the study, once NI-0501 administration has started. As it is recommended in other HLH protocols, CsA concentrations should be monitored at least weekly to maintain trough levels of 150-200 ng/ml.
Concomitant Therapy. Throughout the study, investigators may prescribe any concomitant medications or treatments deemed necessary to provide adequate supportive care except for those listed in Section 6.9. Any medication including over the counter or prescription medicines, vitamins and/or herbal supplements that the participant is receiving at the time of enrollment / randomization or receives during the study through to week 24 must be recorded in the eCRF along with reason for use, dates of administration (including start and end dates) and dosage information (e.g. dose).
Concomitant Therapy. Patients enrolled in this trial may receive any conventional stroke treatment at the discretion of their attending physicians. Patients may not be enrolled in another therapeutic clinical trial until after exit from FAST-MAG after the 90 day visit. Patients may not be treated with other experimental stroke therapies. Treatment with tissue plasminogen activator within 3 hours of symptom onset, after exclusion of intracranial hemorrhage, is encouraged in patients who meet thrombolytic treatment criteria outlined in national consensus guidelines. Since in vitro compatibility has not been tested, a separate IV line should be employed if tissue plasminogen activator and the FAST- MAG trial solution are being infused simultaneously. Prespecified secondary analyses will examine the effect of study treatment in ischemic stroke patients treated with and treated without thrombolytic therapy. Evidence for the safety of concomitant magnesium sulfate and fibrinolytic therapy comes from the absence of adverse interaction among more than 41,000 MI patients receiving both magnesium sulfate and fibrinolytic agents in large cardiac trials, as reviewed above. [1,2] Additionally, the US manufacturer of TPA has on file no reports of adverse interactions between magnesium sulfate and tissue plasminogen activator in preclinical or clinical datasets (personal communication, Xxxxxxx Xxxxx, M.D, Genentech, 9/02) and the FDA Medwatch program has not logged any reports of adverse magnesium-TPA interactions (FDA FOIA inquiry, 9/02).
Concomitant Therapy. Concomitant medications are any prescription or over-the-counter preparations used by subjects during participation in the trial. Use of concomitant medications will be recorded on the Concomitant Medications case report form (CRF) beginning at the Screening Visit until the Week 16/Early Termination visit. The dose and dosing regimen of all prescription and non-prescription therapies and medications, including herbs, vitamins, or other nutritional supplements administered will be documented. Standardized home therapy program including Achilles tendon and plantar fascia stretching exercises and night splints will also be recorded throughout the study.
