Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-ra… (NCT03017963) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-radial Approach.
Netherlands18 participantsStarted 2017-10-06
Plain-language summary
The purpose of this trial is to evaluate the safety and maximum tolerable dose (MTD) of sodium thiosulfate in patients presenting with an acute coronary syndrome and treated with primary percutaneous coronary intervention (PPCI) via trans-radial approach in adjunction to standard treatment.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age ≥ 18 years;
* The diagnosis ACS defined by: chest pain suggestive for myocardial ischemia for at least 30 minutes, the time from onset of the symptoms less than 24 hours before hospital admission, with (STEMI) or without (nSTEMI/uAP) an electrocardiogram (ECG) recording with ST- segment elevation of more than 0.1 millivolt (mV) in 2 or more contiguous leads;
* PCI via trans-radial approach is being considered as treatment;
* Patient is willing to cooperate with the trial during hospitalization
Exclusion Criteria:
* Known cardiomyopathy or LVEF\<35%;
* History of a malignancy treated with chemo- and/or radiotherapy \< 1 year;
* Systolic blood pressure under 100 mmHg or over 180 mmHg at presentation;
* Cardiogenic shock at presentation
* Sedated and/or intubated patients;
* Pregnant/breastfeeding at time of presentation
* The existence of a condition with a life expectancy of less than 1 year;
* A condition which, according to the clinical judgment of the investigator and/or treating physician, does not allow the patient to successfully participate in the study.
What they're measuring
1
Dose limiting toxicity (DLT)
Timeframe: up to 24 hours or discharge from coronary care unit to the ward/home