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Completed

NCT Number: NCT02054000

Intracoronary Tirofiban on No-Reflow Phenomena

The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary percutaneous coronary intervention (PCI).

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Erciyes University School of Medicine

Kayseri, 38039, Turkey (Türkiye)

About this study

The no-reflow phenomenon is one of the most common causes of adverse cardiovascular events in patients with ST-elevated myocardial infarction (STEMI). Re-canalization of infarct related arterial (IRA) flow related to better ventricular performance and lower mortality rate in patients with STEMI. In addition, no-reflow phenomena may limit the benefits of re-canalization of the IRA.

In recent years, many mechanical or pharmacological treatment strategies including adjunctive administration of glycoprotein IIb/IIIa inhibitors (GPI) have been proposed in patients with STEMI. Although current guidelines recommend that small molecule GPI should be administered as an upstream bolus followed by a continuous infusion in patients with STEMI, changes in clinical practice may obviate the need for GPI dosage or routes in current practice. Previous studies have shown that intravenous and intracoronary administration of GPI improve the prognosis and significantly reduce mortality in patients with STEMI. Recently, the Ongoing Tirofiban in Myocardial infarction Evaluation-2 (ON-TIME 2) trial found that the use of tirofiban started during the pre-hospital phase as upstream therapy for primary percutaneous coronary intervention (PCI) and continued for up to 18 hours infusion after the procedure showed an improvement in the markers of reperfusion. Additionally, a reduction was demonstrated in the death in recurrent myocardial infarction in urgent target vessel revascularization and thrombotic bailout. However, in the current literature there are insufficient data regarding the role of intracoronary administration of GPI inhibitors in patients with STEMI who developed the no-reflow phenomenon. The goal of this study was to evaluate the acute effect of intracoronary administration of tirofiban on no-reflow phenomenon in patients with STEMI and occurrence of no-reflow phenomenon undergoing primary PCI.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with ST-elevated myocardial infarction who developed no-reflow phenomena

Exclusion criteria

  • Treatment with thrombolytic drugs in the previous 24 hours
  • Known malignancy
  • Pain to balloon time >6 hours
  • Uncontrolled hypertension (>180/110 mmHg)
  • Bleeding diathesis
  • Thrombocytopenia
  • End-stage liver disease
  • Cardiogenic shock
  • Renal failure
  • Life expectancy of less than 1 year
  • Contraindication for the use of tirofiban.

Treatment and study plan

tirofiban

Drug

Intracoronary administering of Tirofiban

Other names: Glycoprotein IIb/IIIa inhibitor

Placebo

Other

Intracoronary serum physiologic

Primary outcomes

  1. in-hospital mortality

    Time frame: up to 8 days

  2. Non-fatal myocardial infarction

    Time frame: up to 8 days

  3. in-stent thrombosis

    Time frame: up to 8 days

Sponsors and collaborators

Lead sponsor

TC Erciyes University

Other

Registry information

Official study title

Effectiveness of Intracoronary Tirofiban on No-Reflow Phenomena in Patients With ST-Elevated Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Feb 4, 2014
Registry last updated
Feb 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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