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

NCT ID: NCT03797729

Last Updated: 2020-01-22

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-14
• Study Completion Date: 2021-12-31

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.

Conditions

ST Elevation Myocardial Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Normal saline

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: DRUG

Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight\<50kg) or 6ml/hour (patients weight \> 50kg) lasting for 24 hours.

Tirofiban

Group Type: EXPERIMENTAL

Tirofiban

Intervention Type: DRUG

Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight\<50kg) or 6ml/hour (patients weight \> 50kg) lasting for 24 hours.

Interventions

Tirofiban

Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight\<50kg) or 6ml/hour (patients weight \> 50kg) lasting for 24 hours.

Intervention Type: DRUG

Normal saline

Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight\<50kg) or 6ml/hour (patients weight \> 50kg) lasting for 24 hours.

Intervention Type: DRUG

Other Intervention Names

Sodium Chloride Injection

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juying Qian, MD

Role: STUDY_CHAIR

Fudan University

Locations

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhangwei Chen, MD

Role: CONTACT

chen.zhangwei@zs-hospital.sh.cn

+8602164041990 ext. 612747

Hongyi Wu, MD

Role: CONTACT

wu.hongyi@zs-hospital.sh.cn

+8602164041990

Facility Contacts

Zhangwei Chen, MD

Role: primary

chen.zhangwei@zs-hospital.sh.cn

+86 21 64041990

Danbo Lu, PhD

Role: backup

lu.danbo@zs-hospital.sh.cn

+86 21 64041990

Other Identifiers

TRYIT

Identifier Type: -

Identifier Source: org_study_id