drugset
drugset / Trial / NCT03017963

Safety and Tolerability of Sodium Thiosulfate in Patients With an ACS Undergoing CAG Via Trans-radial Approach.

NCT03017963 ↗

Phase 1/2 Completed 18 enrolled University Medical Center Groningen
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-10-06
Primary completion
2018-03-23
Completion
2018-03-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Sodium Thiosulfate Diagnostic / imaging agent 0 g Intravenous
Subject Sodium Thiosulfate Diagnostic / imaging agent 2.5 g Intravenous
Subject Sodium Thiosulfate Diagnostic / imaging agent 5 g Intravenous
Subject Sodium Thiosulfate Diagnostic / imaging agent 10 g Intravenous
Subject Sodium Thiosulfate Diagnostic / imaging agent 12.5 g Intravenous
Subject Sodium Thiosulfate Diagnostic / imaging agent 15 g Intravenous

Indications

acute coronary syndrome