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

NCT03797729 | Unknown Phase 4

• 1 other identifier: TRYIT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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

Keywords

ST Elevation Myocardial Infarction; Tirofiban; Percutaneous Coronary Intervention

Outcome Measures

Primary Outcomes (2)

• TFG(TIMI flow grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).

  TIMI flow grades: grade III.

  Immediately after primary percutaneous coronary intervention.

• TMP(TIMI myocardial perfusion grades) grade III: complete myocardial perfusion immediately after primary percutaneous coronary intervention detected by DSA(Digital Substraction Angiography).

  TIMI myocardial perfusion grades: grade III.

  Immediately after primary percutaneous coronary intervention.

Secondary Outcomes (4)

• Remedial Tirofiban intravenous use during primary percutaneous coronary intervention procedure.

  During the process of primary percutaneous coronary intervention.

• ST segment

  90 minutes after primary percutaneous coronary intervention.

• Myocardial microcirculation perfusion estimated by cardiac magnetic (CMR).

  7 days after primary percutaneous coronary intervention.

• Major adverse cardiovascular events(MACE), including a composite of all-cause death, nonfatal myocardial infarction, stroke, target vessel revascularization.

  30 days after primary percutaneous coronary intervention.

Other Outcomes (7)

• Left ventricular ejection fraction (LVEF) assessed by transthoracic echocardiography.

  7 and 30 days after primary percutaneous coronary intervention.

• The serum microRNA expression pattern changes after primary percutaneous coronary intervention.

  Pre-, 30 minutes, 3 hours and 24 hours after primary percutaneous coronary intervention.

• All the bleeding events assessed by bleeding academic research consortium(BARC) definition for bleeding)

  30 days after primary percutaneous coronary intervention.

Study Arms (2)

Normal saline

PLACEBO COMPARATOR

Drug: Normal saline

Tirofiban

EXPERIMENTAL

Drug: Tirofiban

Interventions

Tirofiban 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.

Tirofiban

Normal saline 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.

Also known as: Sodium Chloride Injection

Normal saline

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Tirofiban; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Tyrosine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Juying Qian, MD

  Fudan University

  STUDY CHAIR

Central Study Contacts

Zhangwei Chen, MD

CONTACT

+8602164041990; chen.zhangwei@zs-hospital.sh.cn

Hongyi Wu, MD

CONTACT

+8602164041990; wu.hongyi@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 1, 2019
• First Posted: January 9, 2019
• Study Start: May 14, 2019
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 22, 2020

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)