Clinical trial NCT03797729: Early Initiation of Low Dose Tirofiban for PPCI in STEMI Patients.
Official title: Early Initiation of Low Dose Tirofiban for Primary Percutaneous Coronary Intervention in Patients With ST-segment Elevation Myocardial Infarction.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST Elevation Myocardial Infarction
Keywords: ST Elevation Myocardial Infarction
Tirofiban
Percutaneous Coronary Intervention
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2019-01-09
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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.

Primary outcomes:
measure: TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
timeFrame: Immediately after primary percutaneous coronary intervention.
measure: TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).
timeFrame: Immediately after primary percutaneous coronary intervention.
Secondary outcomes:
measure: Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.
timeFrame: During the process of primary percutaneous coronary intervention.
measure: ST segment
timeFrame: 90 minutes after primary percutaneous coronary intervention.
measure: Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).
timeFrame: 7 days after primary percutaneous coronary intervention.
measure: Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.
timeFrame: 30 days after primary percutaneous coronary intervention.
Other outcomes:
measure: Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.
timeFrame: 7 and 30 days after primary percutaneous coronary intervention.
measure: The serum microRNA expression pattern changes after primary percutaneous coronary intervention.
timeFrame: Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.
measure: All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)
timeFrame: 30 days after primary percutaneous coronary intervention.
measure: Major bleeding events assessed by TIMI bleeding criteria.
timeFrame: 30 days after primary percutaneous coronary intervention.
measure: Severe or life-threatening and moderate bleeding events assessed by GUSTO bleeding criteria.
timeFrame: 30 days after primary percutaneous coronary intervention.
measure: Major bleeding events assessed by international society on thrombosis and haemostasis(ISTH) bleeding criteria.
timeFrame: 30 days after primary percutaneous coronary intervention.
measure: Adverse events and severe adverse events.
timeFrame: 30 days after primary percutaneous coronary intervention.
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
state: Shanghai
Study officials:
affiliation: Fudan University
name: Juying Qian, MD
role: STUDY_CHAIR
References: