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

Fudan University

Status and phase

Unknown

Phase 4

Conditions

ST Elevation Myocardial Infarction

Treatments

Drug: Tirofiban

Drug: Normal saline

Study type

Interventional

Funder types

Other

Identifiers

NCT03797729

TRYIT

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.