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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Zhongshan Hospital
• Treatments: Tirofiban

Criteria

Inclusion Criteria:

• Time after onset of chest pain: ≥ 30 minutes and ≤ 24 hours;

• ST segment elevated ≥ 0.1mV in adjacent two or more leads;

• Scheduled for primary percutaneous coronary intervention without contraindications;

• Written informed consent is obtained.

Exclusion Criteria:

• Life expectancy ≤ 1 year;

• History of cerebral hemorrhage;

• History of stroke in 6 months;

• Active hemorrhage;

• Severe hepatic and renal dysfunction(ALT > 3 folds of upper limit of normal, eGFR < 30ml/min/1.73mm^2 or Scr > 200 mmol/L);

• Known hemorrhagic diseases;

• Known malignant tumour diseases；

• Active peptic ulcer disease;

• Blood platelet counts < 100×10^9/L;

• Blood hemoglobin < 90g/L;

• Pregnancy or lactation period；

• Take part in other intervention clinical trials；

• Investigators think not suitable to participate in this trial.