drugset / Trial / NCT03797729

Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.

NCT03797729

Phase 4 Unknown 500 enrolled Shanghai Zhongshan Hospital
RandomizedParallel-groupDouble-blindTreatment

Summary

Anti-platelet therapy is a key point of acute myocardial infarction (AMI) treatment. Nowadays, dual anti-platelet therapy based on aspirin and ADP-P2Y12 receptor inhibitor is the preferred treatment before primary percutaneous coronary intervention (PPCI). Restricted by pharmacokinetic and pharmacodynamic characteristics, ADP-P2Y12 receptor inhibitors cannot take effect immediately after oral administration. However, platelet glycoprotein Ⅱb / Ⅲa inhibitors take effect faster. Previous clinical trials indicated that combination of full dose of glycoprotein Ⅱb / Ⅲa inhibitor and dual anti-platelet therapy reduced AMI related ischemia events but increased bleeding events significantly. The high dose of glycoprotein Ⅱb / Ⅲa inhibitor may be the key factor contributing to the increased bleeding events. Therefore, this study aims to evaluate the effectiveness and security of triple anti-platelet therapy based on a small dose of glycoprotein Ⅱb / Ⅲa inhibitor, aspirin and ADP-P2Y12 receptor inhibitor in AMI patients receiving PPCI.

Timeline

Start
2019-05-14
Primary completion
2021-06
Completion
2021-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tirofiban Other / unclassified 4 ml Intravenous
Subject Tirofiban Other / unclassified 6 ml Intravenous